Standard of practice in clinical trials for pharmacy services · DRAFT prepared 20.08.2019....

DRAFT prepared 20.08.2019. Property of The Society of Hospital Pharmacists Australia 1

Standard of practice in clinical trials for pharmacy services 1

Peter Slobodian, BPharm, MClinPharm, MSHP 1, June Challen, B. Pharm, MSHP 2, Michael Ching, 2

BPharm, MPharm, PhD, MSHP 3, Eugenia Hong, BPharm, GradDipRepSc, BSc, MSHP, AMACTA 4, 3

Jasminka Nikolajevic-Sarunac, BPharm MsMedSc Pharmacoepidemiology MFIP MEAHP MSHP 5, 4

Brenda Shum, BSc (Hons), BPharm, MSHP 6, Claire Vosk, B.Pharm, BSc, MSHP 7, and Courtney Munro, 5

BPharm, GradCertPharmPrac, MPharmPrac, MSHP, AACPA 8 6

7

1 Royal Adelaide Hospital Pharmacy, Central Adelaide Local Health Network, SA Pharmacy, Adelaide, 8

Australia 9

2 The Queen Elizabeth Hospital, Central Adelaide Local Health Network, Woodville, Australia 10

3 Austin Health, Heidelberg, Victoria, Australia 11

4 Melbourne Health, Parkville, Victoria, Australia 12

5 John Hunter Hospital, New Lambton Heights, New South Wales, Australia 13

6 Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia 14

7 Monash Health, Clayton, Victoria, Australia 15

8 The Society of Hospital Pharmacists of Australia, Collingwood, Victoria, Australia 16

17

Address for correspondence: 18

Peter Slobodian1, Chair, Clinical Trials Leadership Committee, The Society of Hospital Pharmacists of 19

Australia, Collingwood, Victoria, Australia. Email: [email protected] 20

21

Preface 22

This Standard references and relies upon the SHPA Standards of Practice for Clinical Pharmacy 23

Services 1 as the foremost Standard. This Standard supersedes the previous SHPA Standards of 24

Practice for Pharmacy Investigational Drugs Services 2. 25

This Standard may overlap with others and depending on the area of specialty practice it may be 26

advisable to refer to additional Standards of Practice. 27

The use of the word ‘specialisation’ in this standard is in line with the National Competency 28

Standards Framework for Pharmacists in Australia 3 where ‘specialisation’ refers to the scope of 29

practice rather than the level of performance. ‘Specialisation’ of itself does not confer additional 30

expertise. 31

This Standard is for professional practice and is not prepared or endorsed by Standards Australia. It 32

is not legally binding. 33

34

Introduction 35

In Australia, everyone shares a fundamental right to safe and high-quality healthcare. This is 36

enshrined in the Australian Charter of Healthcare Rights 4 by which all healthcare systems must 37

abide. The Charter summarises the basic rights of patients and consumers when accessing 38

healthcare services including access, safety, respect, partnership, information, privacy and the ability 39

to give feedback. The provision of pharmacy services must encompass the Charter to deliver 40

effective, efficient, timely and equitable patient-centred care. 41

mailto:[email protected]


The National Competency Standards Framework for Pharmacists in Australia 3 complements the 42

underpinnings of the Charter across five domains of competency for the pharmacy profession, 43

namely: (1) professionalism and ethics; (2) communication and collaboration; (3) medicines 44

management and patient care; (4) leadership and management; and (5) education and research. 45

46

Purpose and Definitions 47

The purpose of this Standard is to describe best practice for the provision of clinical trials pharmacy 48

services by clinical trials pharmacists, technicians and, the pharmacy department or employer. It 49

relates to the management of investigational products used in clinical trials and the facilities 50

required for a clinical trials pharmacy services to align with the principles of Good Clinical Practice 51

(GCP) which have their origin in the World Medical Association’s Declaration of Helsinki 5,6. Hospitals 52

and other healthcare agencies are the major centres for clinical trials with investigational products 53

and pharmacists in these institutions should be involved with policies and procedures for the safe 54

and ethical use of investigational products. Implementation of this Standard should ensure the 55

provision of a clinical trials pharmacy service acceptable to the international community. 56

This Standard is intended to be used across hospital pharmacy services in Australia, irrespective of 57

the service type (public or private) or location (metropolitan, regional or rural). While this Standard 58

is intended for hospital pharmacy services, the principles and aspects of patient management 59

discussed herein can be applied to broader pharmacy services that provide clinical trials services. It is 60

acknowledged there are significant variations in pharmacy services that are dependent on 61

organisational capacity, patient population, clinical trials service and pharmacy department 62

priorities, and availability of clinical trials pharmacists; all of which may influence the scope of 63

services. 64

The Standard refers to both the role of the pharmacy service and the pharmacists’ practice in clinical 65

trials. It is intended for both pharmacists involved in clinical trial services and pharmacists whose 66

area of specialisation is clinical trial services and for consistency refers to both as ‘clinical trials 67

pharmacists’. The Standard predominantly refers to clinical trials pharmacists but does not intend to 68

exclude suitably qualified pharmacy technicians where appropriate 1. The SHPA supports both 69

pharmacists and pharmacy technicians to operate at their full scope of practice in order to achieve 70

optimal patient and pharmacy outcomes. 71

72

Objectives of the Service 73

The objectives of a clinical trials pharmacy service are to: 74

• provide safe and ethical use of investigational products by ensuring that they are 75

appropriate for use and are procured, handled, stored and used safely and correctly 76

• apply the principles of best pharmacy practice to the evaluation of new investigational 77

product or medicines 78

• ensure pharmacy aspects of investigational product use comply with relevant legislative 79

Acts, standards and guidelines and with local or institutional policies 80

• consider the safety and welfare of clinical trial participants and the protection of their rights, 81

confidentiality and privacy. 82


Clinical trials pharmacists must deliver the service as part of multidisciplinary collaboration and 83

within the framework of evidence-based and patient-centred healthcare ensuring optimal patient 84

care. 85

86

Scope 87

This Standard applies to all pharmacists working in clinical trials services. The service provided by the 88

clinical trials pharmacist may be delivered across several settings including both public and private 89

hospitals, in an inpatient, outpatient or ambulatory care setting, and in community or domiciliary 90

settings. Users of the service include clinical trial participants and their carers, clinical trials 91

investigator(s) and other health professionals. 92

The scope of services provided by clinical trials pharmacists will be dependent on a variety of factors 93

including: the setting, patient population, the services the hospital or health service provides, 94

funding models, governance structures for clinical trials services, clinical trials service and pharmacy 95

department priorities, organisational priorities and the scope of practice of the individual 96

pharmacist. 97

The role of the clinical trials pharmacist should include: delivery of pharmacy services that improve 98

patient/participant medication outcomes and adds value to healthcare systems, while encouraging 99

the financial sustainability of healthcare; development of and input into policies, procedures, 100

guidelines, and resources; comment on clinical trials protocols; provision of education and training 101

for healthcare professionals and students; and pharmacy research related to clinical trials 102

The pharmacist should be a point of contact for other pharmacists and health professionals, 103

sponsors and for the hospital or health service for investigational product or medicines inquiries 104

related to clinical trials. 105

Whilst the range of services provided in clinical trials is primarily delivered by pharmacists, it is 106

increasingly supported by pharmacy technicians. 107

108

Operation 109

Coordination of the clinical trials pharmacy service should be the responsibility of the clinical trials 110

pharmacist to ensure the maintenance of standards, consistency of service provision, and to ensure 111

clinical trials involving investigational products are conducted according to the principles of GCP. 112

Clinical trials pharmacists should develop services specific to their departmental and institutional 113

needs in accordance with each state policy (e.g. NSW public facilities as per NSW Ministry of Health), 114

yet at a minimum, services should include: 115

• investigational product management, storage, preparation, and dispensing of all 116

investigational products 117

• provisions for emergency 24-hour access to the service 118

• procedures to ensure compliance with protocols 119

• liaison with the investigator(s), trial coordinators, and sponsor representatives 120

• counselling and education of clinical trial participants and monitoring of compliance 121

• providing information to participants and their carers, medical and nursing staff, and other 122

pharmacists as indicated 123


• pharmacy involvement in the institutional review of protocols via membership of a scientific 124

review committee and/or Human Research Ethics Committee (HREC) 125

• involvement in compounding or manufacturing investigational products. 126

The clinical trials pharmacists may be additionally be involved in: 127

• clinical trial design 128

• preparation of blinding plans and unblinding procedures 129

• protocol development 130

• randomisation codes (e.g. for blinded clinical trials) 131

• preparation of placebos and special dosage forms 132

• adverse drug reaction reporting 133

• literature searches 134

• therapeutic drug monitoring 135

• advising on regulatory and non-regulatory aspects of conducting clinical trials 136

• collection and analysis of data 137

• education of pharmacists, pharmacy students, and other healthcare professionals 138

• importation of investigational medicine material 139

• distribution of investigational products to other study sites 140

• managing the financial aspects of the study. 141

142

Policies, Procedures, and Governance 143

Pharmacists must have knowledge of the following documents which provide a framework within 144

which they must practice: 145

• Australian Charter of Healthcare Rights 4 146

• National Safety and Quality Health Service Standards 7 including the National Model Clinical 147

Governance Framework 8 148

• Pharmacy Board of Australia Code of Conduct 9 149

• SHPA Code of Ethics 10 150

• National Competency Standards Framework for Pharmacists in Australia 3 151

• Professional Practice Standards 11 152

• Clinical Governance Principles for Pharmacy Services 12 153

• Relevant legislation Commonwealth, State and Territory Acts, and Regulations including 154

Privacy Act 1988 13. 155

All aspects of the clinical trials pharmacy service should be conducted according to the following: 156

• Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2) - 157

Annotated with TGA comments 5 158

• Access to Unapproved Therapeutic Goods - Clinical Trials in Australia 14 159

• Australian Clinical Trial Handbook: Guidance on conducting clinical trials in Australia using 160

‘unapproved’ therapeutic goods 15 161

• NHMRC National Statement on Ethical Conduct in Human Research 16 162

• NHMRC Australian Code for the Responsible Conduct of Research 17 163


• Code of Good Manufacturing Practice (GMP) 18 164

• PIC/S Guide to Good Manufacturing Practice for Medicinal Products, PE009-13, 01 January 165

2017 166

• Pharmacy Board of Australia Guidelines on the compounding of medicines 19 167

• Commonwealth and state and territory privacy principles and legislation 20. 168

Investigational products in clinical trials should be subject to the same standards of medicines 169

management, dispensing, labelling, participant counselling/education, and medicines information as 170

those required for TGA-registered medicines, with additional requirements as outlined in this 171

Standard. 172

Clinical Trials Protocol Development and Review 173

Pharmacists should be involved in the review of protocols either by the membership of an HREC or a 174

scientific review committee. If there is no clinical trials pharmacist on the committee, there should 175

be an opportunity for prior review by a clinical trials pharmacist of the protocol, to assess the impact 176

on the clinical trials pharmacy service and other pharmacy services. There must be a Research 177

Governance Office (RGO) Site Specific Assessment (SSA) prior to any study being conducted, which is 178

signed by the Head of, or Director of Pharmacy for any trial requiring pharmacy input. 179

Experienced clinical trials pharmacists may be involved in developing or advising on the design of 180

new clinical trials particularly those generated within the institution or without external sponsorship. 181

Other pharmacists with specialist knowledge should be involved as appropriate. 182

Distribution and Control of Investigational Products 183

The Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2) 5 184

recommends that an investigator should delegate responsibility for the investigational product(s) 185

storage and accountability to an appropriate pharmacist. 186

The clinical trials pharmacist/s must sign the trial delegation log and training log held in the 187

Investigator Site File (ISF) upon activation of the clinical trial. 188

The clinical trials pharmacy service should develop and maintain written and up-to-date standard 189

operating procedures (SOPs), including version control, for the handling of investigational products 190

used in clinical trials. 191

Investigational Product Accountability Records 192

Investigational product accountability records should be maintained by the clinical trials pharmacist 193

to identify, at all times, the location and fate of all investigational product received by the site and 194

details of all transactions. 195

Investigational product accountability records should include full details of the following: 196

• investigational product receipt and confirmation at the trial site 197

• dispensing to individual clinical trial participants 198

• investigational product disbursement to usage areas 199

• participant returns 200

• transfers to other institutions 201

• returns to sponsor 202

• authorised destruction by the sponsor 203


• investigational product loss due to breakage, inappropriate storage conditions or 204

unsuitability for use 205

• errors and corrective action that is taken. 206

Investigational product accountability forms provided by the sponsor or purpose-designed forms 207

may be used. Such forms should identify the protocol, clinical trial site, and principal investigator’s 208

name. 209

Black ball-point pens should preferably be used for investigational product accountability records. 210

Any corrections to accountability records should be crossed out with a single line, clearly signed and 211

dated, and have an explanation/comment (if necessary), with the original entry still legible. “White-212

out” or blacking out on any documentation is not permitted. 213

Electronic accountability records may also be used and must be enabled to track all entries including 214

changes by date and electronic login or signature. 215

IVRS/IWRS/IxRS 216

Interactive voice response system (IVRS)/Interactive web response system (IWRS) or Interactive 217

voice/web response system (IxRS) are electronic systems using voice-telephone or web-based 218

platforms for stock control and are routinely used for clinical trials. IxRS should have personalised 219

logins which are password protected to allow for the identification of the person recording the 220

entry. Personalised logins should not be shared or visible to other staff members. 221

Ordering and Receipt of Investigational Product 222

Methods of ordering investigational product vary depending on individual protocols. The clinical 223

trials pharmacist should refer to the specific protocol and/or pharmacy manual for investigational 224

product ordering requirements and procedures. 225

Investigational products should be sent by the sponsor directly to the pharmacy, and specifically to 226

the Clinical Trials area of the pharmacy where possible, and addressed to the clinical trials 227

pharmacist. When receiving investigational products, it is important that information on their safe 228

handling is available to all pharmacy and other staff who may be involved, e.g. Safety Data Sheet 229

(SDS). Occupational health and safety issues are paramount in the handling (i.e. receipt, 230

manufacture, dispensing, disposal, etc.) of investigational products in the early stages of 231

development. 232

The clinical trials pharmacist should physically examine receipts to ensure all investigational 233

products are present, intact, correctly labelled as per shipment documentation and transported 234

under appropriate conditions. It is advisable to inspect and count every individual vial or bottle in 235

multi-pack cartons rather than rely on an outer carton label for contents. The following should be 236

checked and recorded in the investigational product accountability record: 237

• name or identification number of the investigational products 238

• name, strength and dosage form of the investigational products 239

• date of receipt 240

• quantity received 241

• expiry/retest date(s) 242

• batch/lot/serial number(s) 243

• unique code numbers assigned to the investigational product (if appropriate) 244

• numbers and quantity of any randomisation codes or envelopes received. 245


Any discrepancy should be reported to the sponsor directly, and the investigational product 246

quarantined until the discrepancy is resolved. 247

Once shipment documentation has been checked and found correct, or amended/annotated as 248

required, it should be signed and acknowledged as received by faxing or emailing and/or by 249

IVRS/IWRS as required by the sponsor. 250

All shipment documentation should be retained in the pharmacy clinical trials file. 251

Clinical trials pharmacists are sometimes involved in the importation of unregistered medicines. If 252

the unregistered medicine is not available from an Australian sponsor, an overseas source should be 253

found. When importing unregistered medicines from an overseas supplier it is important to obtain 254

the appropriate type of licence and/or permit required, prior to placing an order. Examples of such 255

include: 256

• an import licence and permit issued by the Office of Drug Control Section (DCS) which is 257

required to import narcotic, psychotropic and precursor substances subject to Regulation 5 258

of the Customs Regulations 1956 259

• an import permit issued by the DCS which is required to import antibiotics subject to 260

Regulation 5A of the Customs Regulations 1956 261

• an import permit issued by the DCS which is required to import anabolic and androgenic, 262

hormones, genetically modified organisms, as well as other controlled drugs subject to 263

Regulations 5G and 5H respectively 264

• an import permit through Biosecurity Import Conditions system (BICON) issued by the 265

Department of Agriculture and Water Resources which is required to import biological 266

products used for therapeutic or diagnostic use and containing or derived from 267

microorganisms, animal, human, plant or viral material. 268

Manufacture of Investigational Products 269

To ensure high standards of quality assurance for manufactured investigational products, the 270

standards for the manufacture of therapeutic goods as specified in the SHPA Guidelines for 271

Medicines prepared in Australian Hospital Pharmacy 21 should be followed. The Australian Code of 272

Good Manufacturing Practice for Medicinal Goods-Investigational Medicinal Products 18, in particular 273

Annex 13 - Manufacture of Investigational Medicinal Products, should also be considered. Guidelines 274

for handling cytotoxic medicines and/or targeted therapies should also be adhered to when 275

appropriate 22-24. 276

Storage of Investigational Products 277

Investigational products should be stored separately from the normal pharmacy in an area with 278

access restricted to pharmacy staff, and where possible, access only to clinical trials pharmacists. 279

Investigational products should be separated and labelled on a per-protocol basis. Investigational 280

products should preferably be stored in the pharmacy until needed. If the investigational products 281

are stored outside the pharmacy as agreed upon by the service e.g. to permit emergency access, 282

they should be regularly audited to ensure appropriate storage, investigational product 283

accountability recording, and security of the medicine. 284

Investigational products should be stored at the required temperature and environmental conditions 285

(e.g. humidity) as specified in the protocol, investigator’s brochure or approved product information. 286

They should additionally be stored according to the appropriate statutory regulations for registered 287

medicines and in accordance with any special requirements (e.g. cytotoxic medicines 21). 288


Refrigerators and freezers used to store investigational products should meet local guidelines where 289

they exist for medicines and the National standard for vaccines 25. All refrigerators, freezers and cold 290

rooms must be connected to essential power. 291

There should be a regular monitoring program for all refrigerators, freezers and cold room storage as 292

well as documentation of storage conditions. All refrigerators, freezers, cold rooms and ambient 293

storage areas should be linked to the hospitals building management system and/or a stand-alone 294

validated environmental monitoring system. Alternatively, commercial individual temperature 295

recorders with a back-up alarm system are recommended. Temperature monitors should be serviced 296

and re-calibrated annually and documentation of this kept. Temperature logs should be maintained 297

either in paper form or electronically, and made available to monitors, auditors or investigators on 298

request. 299

In the event of a temperature alarm and/or excursion the following actions should be taken: 300

• check the temperature readings for deviations 301

• quarantine the investigational product and transfer to the back-up facility as per the 302

business continuity plan 303

• note the time of transfer and transfer a portable temperature data logger with the 304

investigational product 305

• notify the sponsor as soon as practical (including a copy of the temperature readings) 306

• do not dispense the quarantined investigational product until authorised to do so by the 307

sponsor 308

• contact an appropriate technician to investigate the alarm and/or excursion and if required 309

to repair equipment. Obtain and file the technician’s report which may include preventative 310

measures for future incidents 311

• write a file note or report of the alarm and/or excursion incident and file it with the relevant 312

temperature records. 313

Quarantine of Investigational Products 314

In addition to storage temperature deviations that require the quarantine of investigational products 315

(see above), other reasons for quarantine may include shipping temperature deviation, damage of 316

investigational products, expiry of investigational products, or any event to cause questioning the 317

integrity of the product. Quarantined investigational products should be clearly identified and 318

segregated from working investigational products. The sponsor should be contacted as soon as 319

practicable, and investigational products should only be made available for dispensation when 320

authorised by the sponsor. A file note or record of correspondence regarding the quarantine 321

incident should be kept in the clinical trials pharmacy folder. 322

Expiry date monitoring 323

Investigational products under development often have limited stability data. The investigational 324

product may have re-test dates instead of an expiry date. Re-test dates need to be regularly updated 325

and the investigational product relabelled as new storage stability data becomes available. A system 326

for monitoring short-dated investigational product also needs to be implemented. 327

Dispensing of Investigational Products 328

Specific dispensing instructions should be developed per-protocol (according to the Clinical Trials 329

Pharmacy SOPs. The specific dispensing requirements for each visit should be detailed. 330


Requirements during dispensing include the following: 331

• verification that the protocol has HREC approval (prior to first clinical trial dispensing) 332

• verification that the prescriber is an authorised investigator i.e. listed on the HREC 333

application/approval, or if not listed that the prescriber is authorised by the Principal 334

Investigator (PI). Approval for this authorisation from leading or local HREC is not necessary 335

• Addition: Verification that the prescriber is an authorised prescriber as per State & 336

Territories legislation e.g. unregistered Schedule 8 medication must be authorised by state 337

authority 338

• verification that the participant (for whom the prescription is written) is registered on the 339

clinical trial 340

• concordance of dosage and regimen with the protocol 341

• confirmation that the participant meets the requirements for treatment (if appropriate) 342

• compounding of sterile preparations (if required) as per the specific clinical trial 343

requirements 344

• concordance of concomitant and disallowed therapy with the protocol 345

• verification of correct randomisation (if required) 346

• verification of IWRS allocation 347

• the requirement for a second check of all randomised prescriptions 348

• completion of accountability records 349

• completion of batch records for compounded items 350

• labelling with a standard pharmacy dispensing label such that the clinical trial, investigator 351

and institution can be identified at all times and in accordance with the protocol. Sponsor 352

required information should not be obscured 353

• retention of additional documentation such as original prescriptions and computer records 354

in a readily accessible manner to allow verification of the dispensing records. 355

Investigational product accountability record(s) should be completed at the time of dispensing by 356

the dispensing pharmacist. The following information should be included in the accountability form: 357

• identification of the clinical trial by protocol number 358

• clinical trial site 359

• name of the PI 360

• name, strength and dosage form of the investigational product 361

• participant initials (as required) 362

• participant clinical trial assigned identification (ID) number 363

• date of dispensing 364

• dosage and quantity dispensed 365

• batch and re-test (expiry) date of investigational product 366

• dispensing pharmacist’s signature. 367

Accountability records for investigational products may also include: 368

• balance of investigational product at a site 369

• date and quantity of returned investigational product 370

• kit numbers and/or stickers for participant-specific investigational product 371

• date of the destruction of investigational product 372


• protocol-specific information e.g. weight/BSA of the participant, the volume of medicine. 373

A clinical trial participant master list with full name and hospital record number (for pharmacy use), 374

clinical trial ID number and randomisation arm/dose level (if appropriate) should be maintained. 375

While the dispensing record may include specific participant details such as name and address, any 376

records forwarded to the sponsor must not contain participant identifying information, other than 377

initials and/or clinical trial assigned ID number. 378

Electronic accountability records may also be maintained by the pharmacy. The electronic system 379

must have a personalised login system which identifies the pharmacist recording entries and contain 380

security to prevent unauthorized access. If original data is modified the system should maintain a 381

viewable audit trail that shows the original data as well as the reason for the change, name of the 382

person making the change and date of the change. An adequate backup system must be employed 383

to prevent loss of data. Originals or validated copies of all prescriptions or clinical trial investigational 384

product orders should be kept to validate accountability records. 385

Return of Investigational Products by Participants 386

Clinical trial participants should return any unused investigational products or empty containers to 387

the pharmacy. Date and quantity of participant returns (or the number of empty containers) and 388

signature of person recording participant returns should be documented in the investigational 389

product accountability records. Returned investigational product should be stored such that it is 390

clearly distinguishable from undispensed investigational product until confirmation by a trial monitor 391

and returned to the sponsor or destroyed. Any participant names or identifiers (other than initials 392

and/or clinical trial ID numbers) on the containers should be removed or blacked out before 393

returning to the sponsor to maintain participant confidentiality. Re-dispensing of returned 394

investigational products should only be performed in exceptional circumstances. 395

For any potentially dangerous or contaminated products used or unused by participants (e.g. 396

needles, syringes, broken ampoules) participants should be supplied with an appropriate sealed 397

container provided by the sponsor. The handling of dangerous or contaminated investigational 398

products should be consistent with work health and safety or occupational health and safety Acts 399

and Regulations, as well as any relevant local, state, or Commonwealth policies. If a potentially 400

dangerous or contaminated investigational product is returned to Pharmacy, it is recommended that 401

this is destroyed as soon as possible after receipt, by usual pharmacy procedures. 402

For returned investigational products and particularly for oral cytotoxic and other hazardous 403

medicines gloves should be worn and counting devices cleaned after each use as per relevant local 404

guidance 22,23,27. 405

Transfer/Distribution to other Institutions 406

Investigational product should only be transferred to another site with the permission of the 407

investigator and the sponsor. All transfers should be recorded on the investigational product 408

accountability records and receipt should be acknowledged. Investigational products should be 409

transferred under the required temperature storage conditions as specified in the protocol. Records 410

of temperature during transit and upon receipt need to be kept. Transfer of cytotoxic medicines or 411

genetically modified products that are also investigational products requires additional precautions 412 23. 413

An authorised recipient at the receiving institution should be responsible for the receipt of 414

investigational product. The authorised recipient should be provided with pertinent information 415


including participant details (if applicable), protocol or relevant medicines information, local 416

investigator, storage and handling instructions, investigational product accountability details and 417

forms, contact names and telephone numbers. Transfer records should be kept at both sites. 418

Return and Disposal of Investigational Products 419

Investigational products may be returned to the sponsor due to the following reasons: 420

• the trial is completed or closed 421

• a participant has returned unused investigational product to the pharmacy 422

• the investigational product has expired and re-test (expiry) date will not be extended 423

• the investigational product has been stored improperly 424

• the investigational product is damaged 425

• the sponsor has requested the return of the investigational product. 426

Alternatively, the sponsor may authorise the destruction at the clinical trials site. This is usually done 427

by incineration at high temperature or by appropriate destruction methods, in accordance with SOPs 428

of the clinical trials pharmacy. The SOPs need to include specific details of the sites destruction 429

procedures. 430

All returns of investigational product approved for destruction should be recorded in the 431

investigational product accountability records, with details recorded including batch/kit numbers 432

quantity, and date of destruction. Destruction records should also be completed and kept in the 433

pharmacy file detailing the investigational product, strength, batch/kit number, expiry (re-test) date, 434

quantity, and date of destruction. In addition, records of randomisation codes returned to the 435

sponsor or destroyed should be recorded. 436

Retention and Archiving of Records 437

All records relating to the clinical trial should be retained in a secure accessible place following trial 438

closure for a minimum of 15 years for adult participants and 25 years for paediatric participants, or 439

for longer if required by the sponsor 5. The clinical trials pharmacy service should have an SOP for 440

archiving of pharmacy records. The system used for archiving must allow for retrieval in a timely 441

manner of any pharmacy study file or non-study specific documentation, such as temperature 442

monitoring records, training records of pharmacy staff, etc. Increasingly, archiving of records may be 443

off-site and pharmacy may choose to be responsible for original prescriptions and invoicing, and 444

return other documentation to the site for archiving. Some states and territories have guidance 445

regarding retention and archiving of records. 446

Documentation 447

Standard Operating Procedures (SOPs) 448

The clinical trials pharmacy service should have written SOPs for all standard services such as clinical 449

trial set up, receipt of the investigational product, temperature monitoring, archiving, etc. 450

File Notes 451

Any event occurring during the administration of a clinical trial which is unexpected, unusual, or falls 452

outside the protocol (e.g. dispensing error, temperature excursion) should be documented in a file 453

note. This is important in explaining anomalies for monitoring and auditing purposes. 454


Training 455

Documentation of training should be kept for each protocol with a record of pharmacists and 456

technicians trained. Protocol and investigator brochure (IB) amendments involving changes in 457

pharmacy procedures require all pharmacists and technicians working with the trial to be retrained 458

and a record of this re-training must be kept. 459

Clinical Trial Participant Care 460

Clinical Trial Participant Education 461

The clinical trials pharmacist needs to work closely with study staff involved with the participant’s 462

treatment to ensure that education regarding investigational products is adequate and appropriate. 463

The participant will have been given written information by the investigator during the informed 464

consent process. However, supplementary education by the clinical trials pharmacist is considered 465

the best practice to ensure protocol compliance and safe and appropriate use of investigational 466

products. 467

An information leaflet may be used to assist this process, and verbal education should reinforce 468

written information. Information leaflets provided to participants will require HREC and sponsor 469

approval. 470

Monitoring Compliance 471

Participant compliance and its monitoring are important in clinical trials and clinical trials 472

pharmacists should: 473

• promote participant compliance by ensuring they understand the education given and the 474

importance of investigational product compliance 475

• check at regular intervals appropriate to the clinical trial (as per-protocol/sponsor requirements) 476

that each participant is following instructions for the correct use of the investigational product 477

• counsel participants to return all investigational product at each visit 478

• ensure that records are kept for returns of used and unused supplies and/or packaging, as 479

required by the sponsor 480

• notify the study staff if a participant has not adhered with the protocol or sponsor requirements 481

• attempt to recover all investigational products from participants (or other sources) at the end of 482

each treatment period. 483

Investigational Product Information 484

Adequate investigational product information should be provided to ensure that the health 485

professional can fulfil their duty of care to the participant. Issues of commercial confidence must be 486

considered. Reproduction of any part of a commercially-sponsored protocol or IB is not permissible 487

as a means of providing the required information without approval from the sponsor. 488

The clinical trials pharmacy should have access to the current protocol, IB (or equivalent) and 489

pharmacy manual for each clinical trial. 490

Medical, nursing, pharmacy and study staff who will be involved in caring for the participants should 491

have access to information about the investigational medicine(s) being used in the clinical trial. 492

Serious Adverse Event Reporting 493

Serious Adverse Events (SAE) need be reported as per regulatory requirements governed by the TGA 494

and GCP requirements. The clinical trials pharmacist should be familiar with the Australian adverse 495


event reporting system via the TGA and may assist the investigator in detecting and reporting 496

adverse events 5,14. 497

Liaison with clinical pharmacists, medical and nursing staff are encouraged to assist in the early 498

detection of an unexpected participant admission to hospital (classified as a SAE) 14. The investigator 499

or clinical trial coordinator should be notified as soon as possible. Hospital automatic electronic 500

reporting systems may assist with this process. If clinical trial participants from other institutions are 501

identified, the clinical trials pharmacist/trial coordinator or investigator at that institution should be 502

notified. 503

Randomisation Codes 504

IWRS systems for randomisation are now commonly used. For studies not using IWRS a copy of the 505

randomisation code should be retained by the study site or pharmacy in the pharmacy file as 506

appropriate, to allow 24-hour access. The requirements to be met before breaking the code 507

(emergency un-blinding) should be stated clearly to prevent inappropriate breaking of the code. Any 508

premature un-blinding (e.g. accidental or due to an SAE) should be documented and explained to 509

the sponsor by the investigator or clinical trials pharmacist. 510

A record of receipt and return to the sponsor of all randomisation codes should be kept in the 511

pharmacy file. 512

Confidentiality 513

The confidentiality of the participant and the research must be maintained at all times. Access to 514

clinical trials pharmacy study records should be provided only to authorised study staff including 515

unblinded monitors and auditors. Compliance with privacy legislation (State and Commonwealth) is 516

mandatory 20. 517

Resources 518

The resources recommended for the efficient provision of a clinical trials pharmacy service include: 519

• adequate staffing levels (see 520

• Recommended Staffing) 521

• facilities and equipment suitable for appropriate dispensing, compounding and aseptic 522

manufacture of investigational products 523

• sufficient and secure storage space (including refrigeration/freezers) to allow separation 524

of the investigational product for each clinical trial (including investigational product 525

returned by participants) with restricted access to clinical trials pharmacy staff 526

• appropriate temperature and humidity control for all clinical trial storage areas, 527

including a 24-hour continuous temperature monitoring system 528

• a dedicated and secure area with sufficient space for administration and 529

monitoring/auditing of clinical trials as well as for counselling participants on 530

investigational products 531

• space for archiving of records as appropriate 532

• access to information technology and services 533

• access to participant medical records including pathology results as needed 534

• access to a medicines information service 535

• copies of relevant documentation as listed in Appendix 1: Resource documents required 536

for use. 537


538

Recommended Staffing 539

The staffing structure and levels required for a clinical trials pharmacy service will be determined by 540

four major factors: (1) the number of clinical trials undertaken at the institution, (2) the complexity 541

and phase of those clinical trials; (3) the rate at which new trials are being opened and closed; and 542

(4) participant recruitment. 543

Support staff, under supervision and with training, may be used for functions such as investigational 544

product control, data entry, manufacturing, and clerical tasks. Qualified pharmacy technicians may 545

assist with dispensing under supervision. 546

Workload 547

Workload records can help in costing and determine staffing levels for clinical trials pharmacy 548

services. Workload records could include: 549

• the number of dispensings by category e.g. 550

o simple dispensing (average dispensing and recording time less than 15 minutes) 551

o standard dispensing 552

o complex dispensing (dispensing and recording time greater than 45 minutes) 553

o sterile preparations 554

o sterile cytotoxic preparations 555

• the number of clinical trials opened and closed 556

• the number of monitor visits 557

• the number of occasions and details of advice/education given concerning concomitant 558

medications, protocol compliance, dose modifications, etc. 559

560

Training and Education 561

It is essential to develop the pharmacy workforce through the training and education of pharmacists 562

and technicians to enable the delivery of best practice in clinical trials. Pharmacists and pharmacy 563

technicians starting practice in a clinical trial pharmacy service must be provided with an appropriate 564

orientation and training program and be familiar with the documents listed in Appendix 1. Ongoing 565

education and training are important to ensure compliance with the requirements of state and 566

federal legislation as well as professional standards and guidelines. 567

Clinical trials pharmacists should have a scope of practice competency profile with a continuing 568

professional development (CPD) plan that covers the five domains of professional performance as 569

per the National Competency Standards Framework for Pharmacists in Australia 2016.3 Although the 570

framework itself is not tied to any area of specialisation, for clinical trials pharmacists there are 571

qualifications, educational activities, knowledge, and skills that are recommended in addition to 572

those of a clinical pharmacist. These have been informed by the SHPA Clinical Trials Leadership 573

Committee. 574


Credentialing and Qualificationsi 575

Desirable certification, credentialing and qualifications for clinical trials pharmacists include: 576

• a postgraduate qualification in clinical pharmacy 577

• credentialing as an Advancing or Advanced Practice Pharmacist provided by Pharmacy 578

Development Australia 28. 579

Educational Activities 580

Recommended continuing education activities for clinical trials pharmacists include those offered by 581

the following organisations: 582

Domestic: 583

• SHPA Seminars and SHPA online CPD activities 584

• Association of Regulatory and Clinical Scientists (ARCS) 585

• Praxis courses 586

• NHMRC eLearning Modules. 587

International: 588

• European Association of Hospital Pharmacy (EAHP) Clinical trial regulation 589

• TransCelerate. 590

Additional sources of information, training, and updates that should be available include: 591

• TGA publications, newsletters, and seminars 592

• NHMRC seminars and publications. 593

Educational material and resources are additionally provided on the SHPA Specialty Practice clinical 594

trials stream page on the SHPA online CPD website. For clinical trials pharmacists, joining and 595

actively participating in the SHPA Specialty Practice clinical trials stream at the Practice Group level is 596

strongly recommended. 597

Attendance at specialist conferences and educational meetings should be supported to maintain and 598

update specialist knowledge in clinical trials. Relevant conferences include those organised by SHPA, 599

the Australian Clinical Trials Alliance (ACTA) and the Association of Regulatory and Clinical Scientists 600

(ARCS). 601

Knowledge, Skills and Experiential Learning 602

Pharmacists responsible for investigational products which are not currently registered for human 603

use in Australia should have a detailed knowledge of the process of medicines regulation in 604

Australia. Pharmacists in contact with participants will need to be knowledgeable about their specific 605

protocol. 606

Essential skills include: 607

• Good Clinical Practice (GCP) training every 3 years 29 608

• Good Manufacturing Practice (GMP) training. 609

Desirable skills include: 610

i This is a limited list offered for general information and does not represent endorsement of any particular provider; new providers may emerge, and this is list is current as of July 2019.

https://www.shpa.org.au/events

https://shpa.moodle.com.au/

https://www.arcs.com.au/

http://praxisaustralia.com.au/

https://www.australianclinicaltrials.gov.au/nhmrc-elearning-modules

http://www.eahp.eu/practice-and-policy/clinical-trial-regulation

https://transceleratebiopharmainc.com/

https://shpa.moodle.com.au/course/view.php?id=227

https://shpa.moodle.com.au/course/view.php?id=227

https://www.shpa.org.au/

http://www.clinicaltrialsalliance.org.au/




• knowledge of basic research methodology 611

• a postgraduate qualification in a field related to clinical trials e.g. 612

o drug development or pharmacology 613

o credentialing as an Advancing or Advanced Practice Pharmacist. 614

• training and education in manufacturing of cytotoxic and hazardous substances. 615

Clinical trials pharmacists should additionally play an active role in the education and training of: 616

• undergraduate pharmacists 617

• provisionally registered pharmacists 618

• practising pharmacists involved with participants 619

• pharmacy technicians involved with participants 620

• research nurses and clinical trial co-ordinators 621

• research data managers 622

• other health professionals involved with participants. 623

Clinical trials pharmacists should undergo evaluation of their clinical skills through the clinCAT 624

(version 2) 1. 625

Training and education will predominately be work-based education and should follow adult 626

learning principles. Further information can be found in Chapter 10 of the SHPA Standards of 627

Practice for Clinical Pharmacy Services 1. 628

629

Key Performance Indicators 630

Key performance indicators (KPIs) should be developed for the major components of the clinical 631

trials pharmacy service. Suggestions for KPIs include: 632

• full-time equivalent (FTE) budget within 10% of revenue (aim for balanced) reviewed 633

quarterly 634

• start-up turnaround (from site selection visit [SSV] to site initiation visit [SIV]) 635

• dispensing statistics (number of scripts and participants/month) 636

• number of requests for costing quotes (services) 637

• number of SSVs 638

• number of SIVs 639

• number of compounded items/complexity of compounding 640

• uncovered leave (e.g. sick leave) and overtime 641

• protocol amendments and/or review 642

• performance at GCP audit and/or during monitoring visits. 643

The frequency of data collection and the number of indicators chosen will depend on the size and 644

scope of the clinical trials pharmacy service. Audits should be conducted by persons independent of 645

those responsible for the clinical trial. All data and documentation should be available for inspection 646

by regulatory authorities. 647

The Australian Commission on Safety and Quality in Health Care and the Australian Government 648

Department of Health, in consultation with clinical trial experts and representatives from all 649

Australian states and territories, is developing the National Clinical Trials Governance Framework for 650

https://www.safetyandquality.gov.au/standards/clinical-trials


public and private healthcare organisations and trials sites to support the delivery of high-quality 651

clinical trials. 652

653

Research 654

Clinical trials pharmacists are encouraged to participate in and contribute towards advancing the 655

knowledge and evidence for investigational products and research. Clinical trials pharmacists are 656

likely to be well-positioned with opportunities for research, particularly so for investigator-driven 657

studies where investigators may approach the clincial trials pharmacist for advice, resources, and 658

solutions to address challenging clinical trials or investigational product issues. It is advisable to 659

clarify and establish upfront if the work and services provided by the clinical trials pharmacist mean 660

an invitation for formal collaboration on the protocol and grants (e.g. co-investigator status, 661

authorship on publications, etc.). There are many areas where clinical trials pharmacists can 662

significantly contribute to collaborative research, including the following: 663

• advice in clinical trial design, and stratification of treatment arms 664

• design, generation, and implementation of randomisation schedules 665

• innovation and formulation of blinded dose forms (e.g. investigational product 666

encapsulation, blinded aseptic products) 667

• assessing the chemical stability of drug in an investigational or off-label formulation. 668

External funding enables larger and possibly multi-centre studies to be conducted. The SHPA funds 669

research grants, practitioner grants, and educational grants. Presentation and publication of studies 670

by Australian pharmacists practising in clinical trials are imperative, to aid others and to illustrate 671

where clinical trials pharmacists are involved in research and how they are improving 672

patient/participant care. 673

The choice of a journal to publish in depends on consideration of the best audience for the study 674

results. The Journal of Pharmacy Practice and Research (JPPR) presents findings to primarily an 675

Australian pharmacy audience. 676

Further information on research can be found in Chapter 11 of the SHPA Standards of Practice for 677

Clinical Pharmacy Services 1. 678

679

Acknowledgements 680

The SHPA additionally wish to acknowledge the work of the former SHPA Committee of Specialty 681

Practice in Investigational Drugs on previous versions of this Standard, including Kay Hynes, Jillian 682

Davis, Helen Kopp, Angela Morris, Carol Rice and Helen Matthews, as well as Eugenia Hong, Michael 683

Ching, Peta Breitag and Mei Grant of the former SHPA Committee of Specialty Practice in 684

Investigational Drugs for contribution to a previous draft of this Standard. 685

686

References 687

1. SHPA Committee of Specialty Practice in Clinical Pharmacy. SHPA Standards of Practice for 688 Clinical Pharmacy Services. Journal of Pharmacy Practice and Research 2013; 43(No. 2 689 Supplement): S1-69. 690

2. SHPA Committee of Specialty Practice in Investigational Drugs. SHPA Standards of Practice for 691 Pharmacy Investigational Drugs Services. 2006. 692

https://www.shpa.org.au/jppr


3. Pharmaceutical Society of Australia. National Competency Standards Framework for 693 Pharmacists in Australia. Deakin West ACT 2600; 2016. 694

4. The Australian Commission on Safety and Quality in Health Care. Australian Charter of 695 Healthcare Rights. 2nd ed; 2019. 696

5. Therapeutic Goods Administration. ICH Guideline for Good Clinical Practice-Annotated with 697 TGA comments. 2018. https://www.tga.gov.au/publication/note-guidance-good-clinical-698 practice. 699

6. World Medical Association. Declaration of Helsinki – Ethical Principles for Medical Research 700 Involving Human Subjects. Brazil: World Medical Association; 2013. 701

7. Australian Commission on Safety and Quality in Health Care. National Safety and Quality 702 Health Service Standards. Medication Safety. Sydney: Australian Commission on Safety and 703 Quality in Health Care; 2017. p. 86. 704

8. Australian Commission on Safety and Quality in Health Care. National Model Clinical 705 Governance Framework. Sydney, NSW; 2017. 706

9. Pharmacy Board of Australia. For Pharmacists Code of Conduct. March 2014 ed; 2014. 707 10. The Society of Hospital Pharmacists Australia. SHPA Code of Ethics. Governance. Collingwood: 708

The Society of Hospital Pharmacists of Australia; 2016. p. 1. 709 11. Pharmaceutical Society of Australia. Professional Practice Standards Version 5. Deakin West 710

ACT 2600.; 2017. p. 116. 711 12. Pharmaceutical Society of Australia. Clinical Governance Principles for Pharmacy Services 712

2018. Deakin West, ACT, Australia: Pharmaceutical Society of Australia, 2018. 713 13. Privacy Act 1988. Compilation No 80. Australia: Office of Parliamentary Counsel, Canberra; 714

2018. p. 380. 715 14. Therapeutic Goods Administration. Access to unapproved therapeutic goods - Clinical trials in 716

Australia. ACT; 2004. 717 15. Therapeutic Goods Administration. Australian clinical trial handbook: Guidance on conducting 718

clinical trials in Australia using ‘unapproved’ therapeutic goods. In: Department of Health, 719 editor.; 2018. 720

16. National Health and Medical Research Council, Australian Research Council, Universities 721 Australia. National Statement on Ethical Conduct in Human Research 2007 (Updated 2018). 722 2018. 723

17. National Health and Medical Research Council. Australian Code for Responsible Conduct of 724 Research. 2018. 725

18. The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation 726 Scheme. Guide to Good Manufacturing Practice for Medicinal Products - Annex 13 - 727 Manufacture of investigational medicinal products. 2017. 728

19. Pharmacy Board of Australia. Guidelines on compounding of medicines. 2017. 729 20. National Health and Medical Research Council. The regulation of health information privacy in 730

Australia. 2004. 731 21. SHPA Manufacturing Working Party. SHPA Guidelines for Medicines Prepared in Australian 732

Hospital Pharmacy Departments. 2010. 733 22. SHPA Committee of Specialty Practice in Oncology. SHPA Standards of Practice for the Safe 734

Handling of Cytotoxic Drugs in Pharmacy Departments. Journal of Pharmacy Practice & 735 Research 2005; 35(1): 44-52. 736

23. SHPA Committee of Specialty Practice in Cancer Services. SHPA Standards of Practice for the 737 Transportation of Cytotoxic Drugs from Pharmacy Departments. Journal of Pharmacy Practice 738 & Research 2007; 37(3): 234-5. 739

24. Alexander M, King J, Bajel A, et al. Australian consensus guidelines for the safe handling of 740 monoclonal antibodies for cancer treatment by healthcare personnel. Intern Med J 2014; 741 44(10): 1018-26. 742

https://www.tga.gov.au/publication/note-guidance-good-clinical-practice

https://www.tga.gov.au/publication/note-guidance-good-clinical-practice


25. Department of Health. National vaccine storage guidelines strive for 5. 3rd ed: 743 Commonwealth of Australia as represented by the Department of Health. 744

26. Booth J, Keith C, Tanner F, Siderov J, Aminian P. Hazardous non-cytotoxic medicines: 745 uncertainty around safe handling? A new workplace guideline for hospital staff. Journal of 746 Pharmacy Practice and Research 2018. 747

27. Power LA, Polovich M. Safe Handling of Hazardous Drugs: Reviewing Standards for Worker 748 Protection. PHARMACY PRACTICE NEWS 2018; (SE2018): 16-28. 749

28. Pharmacy Development Australia. Advancing Practice Background and Guiding Principles, 750 2018. 751

29. TransCelerate. GCP Mutual Recognition. 2019. 752 https://www.transceleratebiopharmainc.com/gcp-training-attestation/ (accessed 27/05/2019 753 2019). 754

30. Therapeutic Goods Administration. Special Access Scheme: Guidance for health practitioners 755 and sponsors. ACT; 2017. 756

31. Therapeutic Goods Administration. Human Research Ethics Committees and the Therapeutic 757 Goods Legislation. In: Department of Health and Aged Care, editor.; 2001. 758

32. National Health and Medical Research Council. Ethical conduct in research with Aboriginal and 759 Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders. 760 Canberra: Commonwealth of Australia:,, 2018. 761

33. European Association of Hospital Pharmacists (EAHP). EAHP Statement on Clinical Trials. 2012. 762 p. 4. 763

764

https://www.transceleratebiopharmainc.com/gcp-training-attestation/


Appendices 765

Appendix 1: Resources 766

Resource documents required for use

• Therapeutic Goods Administration. ICH Harmonised Guideline. Integrated Addendum to ICH

E6(R1): Guideline for Good Clinical Practice-Annotated with TGA comments 2018 5

• Australian clinical trial handbook: Guidance on conducting clinical trials in Australia using

'unapproved' therapeutic goods ACT 2018 15

• NHMRC National Statement on Ethical Conduct in Human Research 16

• Protocols and investigator brochures (IB)/TGA approved product information for all clinical

trials;

• Access to unapproved therapeutic goods - the special access scheme (SAS) 30

• Human research ethics committee and the therapeutic goods legislation 15,31

• NHMRC. Values and ethics: guidelines for ethical conduct in Aboriginal and Torres Strait

Islander health research 32

Additional documents that may be of use

• European Association of Hospital Pharmacists (EAHP) Statement on Clinical Trials 201233

Useful Websites

Australian clinical trial handbook https://www.tga.gov.au/publication/australian-

clinical-trial-handbook

Australian New Zealand Clinical Trials Registry

(ANZCTR)

http://www.anzctr.org.au/

Special Access Scheme (SAS): Online system

guidance

https://www.tga.gov.au/publication/special-

access-scheme-sas-online-system-guidance

European Medicines Agency (EMA) Clinical Trial

Regulation

https://www.ema.europa.eu/en/human-

regulatory/research-development/clinical-

trials/clinical-trial-regulation

767

Appendix 2: Definitions 768

Clinical Trial Terms Definition Purpose

Adverse Event (AE) Any undesired action or effect

of an investigational medicine

that occurs during or within a

proscribed period of time

after a trial has ended

Clinical Trial/Clinical Study A planned study in humans To investigate and report

upon the safety and/or

effectiveness of a diagnostic,

therapeutic or prophylactic

medicine

https://www.tga.gov.au/publication/australian-clinical-trial-handbook




https://www.tga.gov.au/publication/special-access-scheme-sas-online-system-guidance

https://www.tga.gov.au/publication/special-access-scheme-sas-online-system-guidance


Phase I Study 14 A study which involves the

first administration of the

medicine in humans.

Usually administered to

healthy volunteers however

for certain medicine classes

such as cytotoxic medicines

may be conducted in

participants suffering from the

condition the medicine is

intended to treat

To determine the safety of the

medicine, its pharmacological

activity, pharmacokinetics,

and tolerance. It may also

identify routes of

administration and

appropriate doses.

Phase II study 14 The first trial of the medicine

in a small number of closely

supervised participants

suffering from the condition

for which the medicine is

intended

To determine efficacy and

safety, therapeutic dose range

and maximum tolerated dose

of the medicine

Phase III study 14 Extended clinical trials in

greater numbers of

participants

To generate clinical efficacy

data and determine the

incidence and nature of

adverse events

Phase IV study 14 Postmarketing studies To compare the medicine to a

wider range of therapies and

further investigate the use of

the medicine in the normal

clinical setting

Clinical Trial Exemption

Scheme for Medicines (CTX) 14

A sponsor submits an

application to conduct a

clinical trial to the TGA for

evaluation and comment

Notification under CTX or CTN

is required for clinical

investigation of

a) Any medicine not

entered in the

Australian Register for

Therapeutic Goods

(ARTG)

b) Any use of a marketed

medicine beyond the

conditions of its

marketing approval

Clinical Trial Notification

Scheme (CTN) 14

The sponsor notifies the TGA

that a clinical trial is to be

conducted. The HREC takes

responsibility for the review of

the data

Good Clinical Practice (GCP) 5 A standard for the design,

conduct, performance,

monitoring, auditing,

recording, analysis and

reporting of clinical trials

To provide assurance that the

data and reported results are

credible and accurate and that

the rights, integrity, and

confidentiality of the trial

participants are protected


Human Research Ethics

Committee (HREC) 16

An institutional committee

whose composition and

function is consistent with the

National Statement on Ethical

Conduct in Human Research

and has notified its existence

to the Australian Health Ethics

Committee

To evaluate and monitor the

conduct of clinical trials

conducted within an

institution

Investigational product Any medicine, reference

product or placebo which is

being tested or used as a

reference in a clinical trial

This may include a TGA-

registered medicine used in a

different formulation or used

for an unapproved indication

or in doses outside the

approved range

Investigator 5 The person responsible for the

conduct of a clinical trial at a

trial site

Principal Investigator 5 The responsible leader of a

team of investigators of a

clinical trial at a trial site

Investigator Brochure (IB) 5 A compilation of the clinical

and non-clinical data on the

investigational medicine(s)

which is relevant to the study

of the investigational

medicine(s) in human subjects

Protocol 5 A document which describes

the rationale, objectives,

study design, identification of

subjects, methodology,

assessments, evaluation,

ethical compliance and

dissemination of results of a

clinical trial

To direct the conduct and

evaluation of a clinical trial

Serious Adverse Event (SAE) Serious Adverse Event (SAE)

or Serious Adverse Drug

Reaction (Serious ADR) Any

untoward medical occurrence

that at any dose: - results in

death, - is life-threatening, -

requires inpatient

hospitalization or

prolongation of existing

hospitalization, - results in


persistent or significant

disability/incapacity, or - is a

congenital anomaly/birth

defect (see the ICH Guideline

for Clinical Safety Data

Management: Definitions and

Standards for Expedited

Reporting)

Suspected Unexpected

Serious Adverse Reaction

(SUSAR)

Sometimes during a clinical

trial for a certain

investigational product, a

subject may experience

serious adverse reactions that

may or may not be dose-

related but are unexpected, as

they are not consistent with

current information

769

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