SOP_GCP01_01 Ingham Institute/SWSLHD Documentation of investigational site qualifications, adequacy of resources and training records Version 2.1 Dated 5 th Oct 2017 Page 1 of 10 Ingham Institute and SWSLHD Standard Operating Procedures for Clinical Trials Documentation of investigational site qualifications, adequacy of resources and training records Version: 2.1, Dated 5 th Oct 2017 Effective Date: 5 th Oct 2017 Review Before: October 2019 DO NOT USE THIS SOP IN PRINTED FORM WITHOUT FIRST CHECKING IT IS THE LATEST VERSION Author: Kelsey Dobell-Brown – Clinical Trials Manager – SWSLHD Approved by: Prof Meera Agar – Clinical Trials Director – Ingham Institute/SWSLHD
Transcript
SOP_GCP01_01 Ingham Institute/SWSLHD Documentation of investigational site qualifications, adequacy of resources and training records Version 2.1 Dated 5th Oct 2017
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Ingham Institute and SWSLHD Standard Operating Procedures
for Clinical Trials
Documentation of investigational site qualifications, adequacy
of resources and training records
Version: 2.1, Dated 5th Oct 2017
Effective Date: 5th Oct 2017
Review Before: October 2019
DO NOT USE THIS SOP IN PRINTED FORM WITHOUT FIRST CHECKING
Approved by: Prof Meera Agar – Clinical Trials Director – Ingham Institute/SWSLHD
SOP_GCP01_01 Ingham Institute/SWSLHD Documentation of investigational site qualifications, adequacy of resources and training records Version 2.1 Dated 5th Oct 2017
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1. PURPOSE
To describe the procedures related to the appropriate documentation of investigational site qualifications and training records as well as the provision of resources to perform clinical research with respect to regulatory requirements.
2. SCOPE
Applicable to all phases of clinical investigation of medicinal products, devices and diagnostics.
3. APPLICABILITY
Principal Investigator, sub-Investigator(s), research co-coordinators and other staff delegated to perform trial-related duties.
4. PROCEDURE
4.1 Documentation of Investigational Site Qualifications and Training Records
The Principal Investigator is responsible for:
a. Maintaining an up-to-date two page Curriculum vitae and review on a second yearly basis that provides evidence of such qualifications through and/or other relevant documentation requested by the sponsor, the HREC, and/or the regulatory authority (ies).
b. Be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial. This should be evidenced in the CV and should include evidence of current ICH GCP training as specified in SOP_GCP10_01 section 4.1
c. Maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties. The list is in the form of a Delegation Log and delegated duties should be captured and signed and dated by the investigator on a per person basis. The delegation log may be provided by the Sponsor Company but for investigator-initiated studies, a site log is required, as specified in SOP_GCP02_01. See also Appendix 2 for a sample template.
d. Maintain a list of training conducted throughout the lifetime of the trial by using a training log. Please see Appendix 3 for a sample template.
e. Actively supervising any individual or party that has been delegated trial-related duties and functions which are conducted at the trial site.
f. If the investigator/institution retains the services of any individual or third party to perform trial-related duties and functions, the investigator/institution should ensure this individual or party is qualified to perform those trial-related duties and functions and should implement procedures to ensure the integrity of the trial-related duties and functions performed and any data generated.
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4.2 Adequacy of Resources
The Principal Investigator should:
a. Be able to demonstrate (if possible based on retrospective data) a potential for recruiting the required number of suitable subjects within the agreed recruitment period. This may be in the form of de-identified subject screening and recruitment logs that can be either paper based or the use of an online spread sheet.
b. Have sufficient time to properly conduct and complete the trial within the agreed trial period and have available an adequate number of qualified staff and adequate facilities for the foreseen duration of the trial to conduct the trial in line with the protocol and adhering to ICH-GCP guidelines.
c. Adequacy of resources are normally determined by a site feasibility assessment for commercially-sponsored and collaborative group studies.
d. Receive Ethics approval and subsequent Site Specific approval prior to commencement of a clinical trial within South Western Sydney local Health District (SSWLHD).
e. If applicable receive notification of approval from the TGA for the use of an Investigational product or device under the CTN or CTX scheme prior to commencing recruitment of participants at the site. Refer to the TGA website for further information. Follow link - http://www.tga.gov.au/
4.3 Training Records
The Principal Investigator(s) should:
a. Ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and functions.
b. Organise an initiation meeting with the Sponsor or Sponsors representative prior to the start of the clinical trial to ensure all persons assisting with the trial have adequate training
c. In the event that the trial is investigator initiated a start up meeting should be conducted to ensure all members of the study team are adequately informed about the protocol and all other requirements of clinical trial management under the auspices of ICH-GCP
d. Ensure that tasks delegated to study staff are documented appropriately. This can be evidenced by the delegation log.
e. Ensure study specific training records are maintained to provide evidence that tasks were delegated following the correct training. This includes ongoing documentation of training with all subsequent protocol amendments once a clinical trial has commenced. A template has been provided in Appendix 3
f. Ensure all trial staff have current ICH-GCP Training kept within the site file or maintained electronically, as per site policy and procedure.
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g. Ensure the Research and Governance office is notified of a change in Principal Investigator or additional investigators at site. Please refer to the following website for updated instructions and templates http://www.swslhd.nsw.gov.au/ethics/
h. If applicable ensure delegated clinical trial staff have the necessary accreditation such as Dangerous Goods Training to enable them to process, pack and send laboratory samples overseas OR
i. Provide evidence that the hospital pathology laboratory has the required accreditation to process, pack and ship samples overseas
j. Provide any other site accreditation as required by the Sponsor or HREC
k. Ensure that if third party providers are being used, evidence of accreditation and/or qualification is provided to the Sponsor as requested.
5. GLOSSARY
Good Clinical Practice (GCP)
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
Human Research Ethics Committee (HREC)
A body which reviews research proposals involving human participants to ensure that they are ethically acceptable and in accordance with relevant standards and guidelines.
The National Statement requires that all research proposals involving human participants be reviewed and approved by an HREC or Executive committee. The method is dependent on the proposal. Please refer to the Research and Ethics Office website for more information.
http://www.swslhd.nsw.gov.au/ethics/how.html
International Conference on Harmonisation (ICH)
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use is a joint initiative involving both regulators and research-based industry focusing on the technical requirements for medicinal products containing new drugs.
Principal Investigator
An individual responsible for the conduct of a clinical trial at a trial site ensuring that it complies with GCP guidelines. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the Principal Investigator. In this instance they may delegate tasks to other team members.
Sub Investigator
Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows).
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6. REFERENCES
1. ICH Harmonised Guideline “Integrated Addendum to ICH E6 (R1): Guideline for Good Clinical Practice E6 (R2) dated 11 June 2015
2. National Statement on Ethical Conduct in Human Research, (2007).
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APPENDIX 1: SOP change log
Version No.
Reason for Issue
1
First issue
2
Revised and updated for further clarification and adherence to the updated ICH-
GCP guidelines E6 (R2)
2.1
Minor administrative changes only
SOP_GCP01_01 DOCUMENTATION OF INVESTIGATIONAL SITE QUALIFICATIONS, ADEQUACY OF RESOURCES AND TRAINING RECORDS
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Insert member organisation logo here
APPENDIX 2: SIGNATURE LOG AND DELEGATION OF DUTIES (TEMPLATE)
SIGNATURE LOG AND DELEGATION OF DUTIES (template)
Protocol No:
Investigator Name:
Sponsor:
Start Date Of
Involvement
Print Name Signature Sample Initials
Function (e.g. sub-investigator,
study nurse)
Task Delegated
Authorised by Investigator (initial+ date)
End date of Involvement
a. Informed discussion g. Investigational product accountability
b. Informed consent sign off
h. Randomization of subjects (e.g. IVRS)
c. CRF/DCF Completion and Correction
i. Essential / Regulatory documents handling
d. CRF/DCF Sign-Off
j. Study specific procedures
e. Subject Examination/evaluation
k. Other
f. Investigational product dispensation
APPENDIX 3
Sample Training Record
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Xx/xx/xxx
Training Log Report Project Title: [Insert Project Title]
HREC Reference: HREC/xx/xxxx/xxx
SSA Reference: SSA/xx/xxxx/xxx
Local Project Number: xx/xxx
Please be advised that the following documents have recently received ethics approval and the
corresponding site specific documents have been approved by the local Governance Office. These
documents are listed below;
Document Version Date
Protocol
Liverpool Hospital Patient information consent form
Summary of amendments (if applicable)
The following delegated investigators and researchers have been notified on [insert date] of the
updated documents (as per attached email):
Name Date of acknowledgement of read documents*
Investigator/Delegate Signature
*Acknowledgement email electronically saved in study folder in CTC Clinical trials drive.
Please note that all superseded documents have been archived and should not be attainable by any
researchers or investigators and only current approved documents will be used.
Name Position Signature Date
Appendix 4 – Sample Curriculum Vitae - Visit website for an electronic version http://www.transceleratebiopharmainc.com/assets/site-qualification-and-training/
CLINICAL TRIALS USE ONLY
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Appendix 4 – Sample Curriculum Vitae - Visit website for an electronic version http://www.transceleratebiopharmainc.com/assets/site-qualification-and-training/
CLINICAL TRIALS USE ONLY
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