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GUIDELINES ON:PHARMACOVIGILANCE IN CLINICAL

TRIALS OF INVESTIGATIONAL MEDICINAL PRODUCTS

March 2009

List of contents

Abbreviations and definitions 3

Introduction to pharmacovigilance in clinical trials 6

Pharmacovigilance sponsor for Tayside-based clinical trials 7

Risk assessment 8

Pharmacovigilance statement in the protocol 9

Guidance on writing the risk assessment and pharmacovigilance statement 9

Deciding what to record in the study record 10

Deciding what investigators report to sponsor 11

Reporting and follow-up of pregnancies in clinical trials 12

Deciding if events are expected and linked to a study drug 12

Recording and reporting NIMPs 14

Unblinding the trial record 14

Reporting events linked to comparitor drugs or placebo 15

Completing the Adverse Event/Adverse Reaction Report form 16

Sponsor reporting to the regulatory agency and the Ethics Committee 13

Reporting SUSARs 17

The MHRA regulatory agency contact details 18

Informing other investigators of SUSARs 19

The Annual Safety Report 19

Appendix 1: Summary table: investigator’s/sponsor’s responsibilities

Appendix 2: Sponsor’s arrangements for processing reports

Appendix 3: Serious Adverse Event and Adverse Reaction Report form

Appendix 4: Annual Safety Report template

Appendix 5: Notification of SUSAR by Pharmacovigilance sponsor

Pharmacovigilance SOP Version 6, March 20092

ABBREVIATIONS AND DEFINITIONS USED IN THE FOLLOWING TEXT

Adverse event (AE)Any untoward medical occurrence affecting a trial subject during the course of a

clinical trial.

Serious Adverse Event (SAE)An adverse event where the death of the subject resulted or was otherwise

threatened or where the subject required hospitalisation or prolonged hospital stay;

or resulted in persistent or significant disability or incapacity; or was a congenital

anomaly/birth defect. Note that investigators may also consider that other adverse

events fall into the ‘serious’ category in that they were important medical events

(other than the above) requiring medical investigation/intervention. These should be

reported accordingly.

Adverse Reaction (AR)An adverse event when there is at least a possibility that it is causally linked to a trial

drug or intervention.

Serious Adverse Reaction (SAR)A SAE that is thought to be causally linked to a trial drug or intervention.

Suspected Serious Adverse Reaction (SSAR)Given that there must always be room for doubt, this really amounts to the same

thing as a SAR. Thus SSAR may occasionally be used in preference to SAR.

Suspected Unexpected Serious Adverse Reaction (SUSAR)The unexpected occurrence of a SAR. Note that there need only be an index of

suspicion that the event is a previously unreported reaction to a trial drug or a

previously reported but exaggerated or unexpectedly frequent adverse drug reaction.

Ethics CommitteeThe Research Ethics Committee (REC) that provided the favourable opinion. This

can be any Ethics Committee that is ‘recognised’ by the UK Ethics Committee

Authority for the purpose of reviewing clinical trials under the regulations. For multi-

site studies, this may be a MREC or Main REC. There is no longer any distinction

between them.


Case Report Form (CRF)The document in which trial data is recorded for individual participants identified by

their unique trial code. The CRF is part of the essential documents in clinical trials

(see ICH GCP).

IMPAn Investigational Medicinal Product or trial drug under investigation.

Clinical trialRefers specifically to a drug study described in the regulations as a Clinical Trials of

an Investigational Medicinal Product or CTIMP.

NIMPNon-Investigational Medicinal Product or a drug administered in a trial as part of the

methodology but not actually a drug under investigation e.g. vasoactive drugs to

assess changes in endothelial function.

NRESThe National Research Ethics Service that has succeeded COREC (Central Office

for Research Ethics Committees) which is contracted to oversee the running of NHS

Research Ethics Committees in Scotland

MHRAThe Medicines and Healthcare products Regulatory Agency, which is the UK

regulatory body that ‘authorises’ a clinical trial by issuing a Clinical Trials

Authorisation (CTA). The MHRA also undertakes statutory inspections of trial sites

and studies in progress.

CTAClinical Trials Authorisation or regulatory approval by MHRA to conduct a CTIMP.


Investigator’s Brochure (IB) and Summary of Product Characteristics (SPC)These are important reference documents that should be available from the

pharmaceutical manufacturer of drugs for use in clinical trials. References copies

should be kept with the Trial Master File. The IB is the source document on available

safety data for unlicensed drugs. The SPC provides the relevant safety data on

licensed medicines.


INTRODUCTION

These guidelines apply to clinical trials sponsored by NHS Tayside or in which NHS

Tayside has agreed to act as the pharmacovigilance sponsor on behalf of another

party.

The guidelines set out the procedure for the reporting of adverse events in clinical

trials in accordance with Part 5 of The Medicines for Human Use (Clinical Trials)

Regulations 2004

The pharmacovigilance strategy in the EU Clinical Trials Directive is designed to

ensure:

The prompt reporting of serious adverse events and the ongoing review of safety

in clinical trials.

The identification of adverse events where an association with a trial drug (or trial

intervention) is suspected.

The effective dissemination of information on SUSARs across the EU and the

research community.

Investigators and sponsors must work together in reviewing adverse events and

reaching decisions about severity and causality and whether or not the events

might have been expected.

Investigators must give consideration to what they should record in the subject’s trial

record (the CRF) and what they must report to the sponsor. In turn, the sponsor

must understand what they are required to report to the MHRA and ethics committee

in accordance with the Clinical Trials Regulations.

An important aim of the pharmacovigilance strategy is to ensure the early recognition

of rare but serious, unexpected or idiosyncratic adverse drug reactions in order to

inform decisions about the future use and development of drugs in practice.

There are THREE stages in the process, as follows:

Stage 1 refers to what is recorded in the research record (CRF).


Stage 2 refers to what is reported by the investigator to sponsor.

Stage 3 refers to what is reported by the sponsor to the MHRA and ethics

committee.

The investigator and sponsor must agree the arrangements for pharmacovigilance

and safety reporting on a trial by trial basis and, following an appropriate risk

assessment, set out their strategy in the trial protocol. The protocol must be

reviewed and approved by the MHRA and ethics committee before a CTA and

favourable ethical opinion can be issued.

See Appendix 1 for a summary of the responsibilities of the investigator and sponsor

regarding the pharmacovigilance arrangements in clinical trials.

THE PHARMACOVIGILANCE SPONSOR

Responsibility for the pharmacovigilance arrangements in clinical trials rests with the

sponsor.

Where two or more organisations are involved, one or other of the parties must

accept responsibility for pharmacovigilance issues. This party is referred to as the

pharmacovigilance sponsor.

NHS Tayside may therefore, by agreement, act as the pharmacovigilance sponsor of

clinical trials conducted by employees of the University of Dundee who retain other

responsibilities as sponsor.

The pharmacovigilance arrangements are organised by the R&D Department on

behalf of NHS Tayside.

For a summary of the arrangements and relevant contact details for the receipt and

processing of SAEs and SARs, including SUSARs, notified by investigators, see

Appendix 2.

THE RISK ASSESSMENT STATEMENT IN THE PROTOCOL


The risk assessment provides evidence that investigators have given due

consideration to safety issues in clinical trials that apply to IMPs, comparators,

NIMPs and related trial interventions.

The risk assessment must take into account what is already known about the drug(s)

in question and what, if any, experience of previous exposure there may have been

in the study population. It follows that the level of risk may be somewhat less in

studies involving licensed drugs that have been in use for some time and prescribed

for large numbers (perhaps tens of thousands or even millions) of patients whose

demographics resemble those of the research participants. In such cases it may be

appropriate to say that the investigators will record known adverse drug reactions in

the CRF but not report them to the sponsor unless they occur with unexpected

frequency or severity.

However, there should be a greater index of suspicion for licensed drugs that are still

designated ‘black triangle’ in the BNF and therefore the subject of intensive safety

monitoring in clinical practice. In such cases, it is recommended that investigators

report all SAEs to the sponsor and that unexpected events be considered potential

SUSARs in the absence of any other obvious cause (e.g. physical injury, accidental

injury, etc).

In relation to drugs tested in Phase I and II studies, especially if ‘first-in-man’ where

there is no information on safety profile, it is likely that the investigators will record all

adverse events in the CRF and notify the sponsor of everything that falls into the

‘serious’ category.

At the other end of the ‘risk’ spectrum is a Phase IV, post-marketing trial, especially if

it involves a drug that has been in use for many years and whose side effect profile is

therefore well known. For example, a clinical trial of allopurinol in the treatment of

endothelial dysfunction in patients with heart failure is unlikely to throw up many, if

any, SUSARs although the occurrence of a known but serious adverse reaction

(SAR) might be an end point in the study and therefore worthy of reporting.

The likelihood that an event, even a death, is a consequence of disease progression

and therefore predictable should also be taken into account. Such events may be

recorded in the CRF but not reported to the sponsor. In the allopurinol example,

above, it is quite likely that trial participants might suffer events related to worsening


heart failure and cardiovascular outcomes which would not normally require to be

reported to the sponsor.

The bar may be raised when an established drug is used in a new population in

whom there has been little, if any, previous exposure. This could apply, say, to a

drug being investigated in the elderly or the very young when these groups have

previously been excluded in the SPC and where there is little experience reported in

the published literature.

THE PHARMACOVIGILANCE STATEMENT IN THE TRIAL PROTOCOL

The protocol is a key document in guiding the recording and reporting of safety

issues in a clinical trial and in setting out the ground rules for what does or does not

need to be recorded in the CRF or reported to the sponsor.

Guidance should be provided in a “Pharmacovigilance and Safety Reporting” section

in the protocol as follows.

A definition of the categories AE, SAE, SAR and SUSAR (see Abbreviations

and Definitions on Page 1 of these guidelines).

The risk assessment statement.

Confirmation that the investigator will ask the participants at each study visit

about events since their previous visit including, in particular, unscheduled

GP visits, hospitalisations, disability or incapacity. Where the risk

assessment demands, the investigators may consider providing participants

with a contact address or telephone number to expedite the reporting of

adverse events.

A statement of what adverse drug reactions WILL NOT be reported to the

sponsor. For licensed medicines, especially if non-black triangle drug, this

might include a list of known ADRs as set out in the SPC, a copy of which

should be added as an Appendix to the protocol. An accompanying

statement in the Pharmacovigilance and Safety Reporting section of the

protocol might be as follows:


Adverse drug reactions listed under ‘Undesirable effects’ in the Summary of

Product Characterisrtics (see Appendix --) that WILL NOT be reported to the

sponsor unless they are considered to be occurring at greater frequency or

with greater severity than might be expected.

A statement of those adverse events that may be predicted as a result of

disease relapse or progression and not therefore requiring to be reported to

the sponsor.

Confirmation of follow-up to outcome and reporting to sponsor with regard to

the occurrence of a pregnancy in a female participant or the female partner of

a male participant where there is a paucity of safety information concerning

foetal exposure and foetal development.

Identification of who is responsible for deciding when unblinding should take

place and who is responsible for carrying out the unblinding. See ‘Unblinding

the trial record’, below.

The name and contact details of the pharmacovigilance sponsor’s

representative should be included for the purposes of reporting

SAE/SARs/SUSARs.

WHAT SHOULD INVESTIGATORS RECORD IN THE CRF?

All adverse events reported at a trial visit should be recorded unless otherwise specified in the protocol. This is part of routine data collection. It may also be

appropriate to record an adverse event in the participant’s medical notes if it is

thought to have a bearing on their current or future care as a patient.

In Phase I (especially if ‘first in man’) and Phase II studies it seems appropriate to

record all adverse events, especially where tolerability or safety is being assessed.

Such studies involve new drugs that are still unlicensed and whose safety profiles are

largely unknown at the time.

Even at the Phase 3 pre-marketing stage, it is likely that the numbers of people who

have previously been exposed to the drug will be in the hundreds as opposed to the

tens of thousands who may receive the drug after it is licensed. In fact a high index


of suspicion should remain in place for licensed drugs until such time that the ‘black

triangle’ has been removed from the entry in the British National Formulary.

Note that even non serious adverse events should be recorded and reported if their

occurrence is important to safety monitoring in a clinical trial or if they are believed to

be adverse reactions critical to the evaluation of drug safety. Likewise, the

occurrence of predictable adverse reactions should be recorded if identified in the

protocol as guiding decisions about dosage adjustment.

REPORTING BY INVESTIGATOR TO SPONSOR

Investigators must recognise that they are responsible for initiating reports and

reporting adverse events and adverse reactions promptly to the sponsor unless

otherwise indicated in the protocol. All investigators must therefore be acquainted

with the Pharmacovigilance and Safety Reporting requirements as set out in the

protocol.

Unless otherwise specified, investigators must report all adverse events (irrespective of causality) that fall into the ‘serious’ category according to the definitions set out on Page 1 of these guidelines.

Investigator should report serious adverse events in a prompt manner. The

regulations state ‘immediately’ but it is likely that some events at least will have

already occurred between study visits and some time before the investigator has

become aware of their occurrence, unless a study ‘hot line’ to self-report events has

been used.

Unless the urgency of the situation demands it i.e. others are thought to be at

immediate risk, investigators should report SAEs at the first opportunity after they

become aware of their occurrence and usually within 24 hours.

Immediate reporting of SAEs or SARs or SUSARS can be by email or fax though

initial advice may also be sought by telephone. Thereafter a signed hard copy of the

detailed written report must be sent by post or fax at the earliest opportunity. A copy

of the detailed written report should be filed in the CRF.


The ‘immediate’ report need only alert the sponsor to the event, the initial decision

concerning causality and expectedness, date of occurrence and the participant’s

unique identifier but full details must be provided in the detailed written report that

follows.

See Appendix 3 for a copy of a detailed written report pro forma.

REPORTING AND FOLLOW-UP OF PREGNANCIES IN CLINICAL TRIALS

Although pregnancy is an exclusion criterion in many CTIMPs, pregnancies continue

to occur despite careful counselling and the provision of contraceptive advice.

Although unexpected pregnancies are not by definition ‘adverse events’ they are of

importance to safety monitoring and must be rigorously followed-up to outcome by

the investigators.

Thus unexpected pregnancies must be reported to the pharmacovigilance sponsor

who will retain a separate record of the event on the Pharmacovigilance database.

Where pregnancy is an exclusion criterion, it follows that the participant should be

withdrawn from the study. However, the investigators must continue to monitor

progress and report the outcome to the sponsor. An abnormal outcome e.g.

congenital anomaly, may then be treated as a SAE and, in the case of an unlicensed

or black triangle drug, reported as a SUSAR.

DECIDING CAUSALITY AND WHETHER OR NOT THE EVENT IS EXPECTED

Where the decision is taken that an adverse event falls into the ‘serious’ category

(i.e. it is elevated to a SAE), the investigator must also decide on the likelihood of an

association with a trial drug (causality). If this is the case, the SAE then becomes a

serious adverse reaction (SAR).

In the case of an SAR the sponsor must then decide if the reaction might have been

expected from what is known about the drug’s side effect and safety profile.

However, in phase IV trials using well established licensed medicines, the

investigator may be well qualified to make this decision which is likely to be accepted

by the sponsor. If in doubt, investigators should discuss expectedness with the

pharmacovigilance sponsor before reaching a decision.


Thus important questions to be answered include:

Is there is a suspicion that the event is related to a study drug, either a test drug

or a comparator, but not a placebo (unless an excipient reaction is suspected)?

Where applicable, is it possible that the event is related to a non-study drug or

NIMP?

Is it expected i.e. is it consistent with the information about the drug’s toxicity

profile set out in the Investigator’s Brochure (unlicensed drugs) or Summary of

Product Characteristics (licensed drug)? A copy of the Investigator’s Brochure or

SPC should be included in the Trial Master File for reference.

Note that the definition of a SUSAR also includes a known adverse reaction of

unexpected severity or occurring with greater frequency than might otherwise be

anticipated.

Reaching a decision about causality and whether or not the SAR is expected should

take into account the pharmacology of the drug, its side effect profile and that of

related compounds, any temporal relationship of the onset of the event with

administration of the drug and whether or not there is another likely cause e.g.

relapse or disease progression.

However, investigators should not be persuaded that there is no causality simply

because the event has not previously been reported. Reporting unexpected events

is the very basis for the early detection of SUSARs and the important point is that

investigators should therefore have reasons for excluding causality. The process is

no different from reviewing adverse events in practice and reporting suspected

adverse drug reactions using the ‘Yellow Card’ reporting mechanism.

Some investigators prefer to grade the likelihood of causality by ticking a relevant box

to indicate the link to a study drug as ‘possible’, ‘probable’ or ‘certain’. In fact, this

has no bearing on what follows and it is only necessary to have an index of suspicion

that the adverse event is an adverse reaction before reporting it to the sponsor.


Where the decision is taken that an adverse event may be linked to a trial drug, the

relevant details should be included in the detailed written report to sponsor (see

Appendix 3).

The sponsor may carry out an independent assessment of an event regarding

causality but the investigator’s decision cannot be over-ruled. If the sponsor

disagrees with the investigator, this should be recorded in the expedited report to

MHRA.

RECORDING AND REPORTING NIMPs

NIMPs or non-investigational medicinal products include drugs that might be

administered as part of a trial’s methodology e.g. in order to create a physiological

baseline or assess an investigational drug’s ability to modulate physiological change.

Examples include vasoactive substances administered to assess changes in forearm

blood flow in response to an intervention, administration of a pharmacological agonist

to test the efficacy of an investigational antagonist, etc.

Investigators and sponsors are also required to document and report adverse

reactions to NIMPs in accordance with the regulations as they apply to investigational

drugs or IMPs. The same 15/7 day timelines apply.

UNBLINDING THE CLINICAL TRIAL RECORD

There may be several reasons for breaking the code in a clinical trial record.

For example, where independent Data Monitoring Committees are in place the

members should be provided with unblinded information in order for them to assess

progress or safety data and any critical efficacy endpoints as information emerges in

the trial.

In a blinded trial, the unblinding may be necessary to confirm that a SUSAR is in fact

linked to the suspect drug. In the past it was customary for the pharmaceutical

sponsor in commercial trials to decide on the expectedness of an adverse reaction

and to unblind the trial record accordingly. Likewise it should therefore be the role of

the sponsor in non-commercial trials to undertake this task.


It is proposed therefore that the Pharmacovigilance sponsor for UoD/NHS Tayside

sponsored trials should separately assess adverse reactions for expectedness and

unblind and report to MHRA and the Ethics committee on this basis. Thus as far as

the investigators are concerned, the blinding is maintained and trial data is not

compromised.

Note also that unblinding in respect of an individual participant may be required in

exceptional circumstances by a treating clinician if it is thought that the identification

of the trial drug has a bearing on the patient’s continuing care. Locally,

arrangements are in place to allow the breaking of study codes for individual trial

participants by the On-call Pharmacy service when required out of hours in an

emergency situation.

The protocol should confirm the unblinding procedure as above and include relevant

names and contact details.

Note that the trial participant’s identity must be protected throughout and in the

detailed written report, and any other subsequent communication, the individual

should be identified only by their unique trial code and age and sex.

COMPARATORS AND PLACEBOS

Clinical trials may be controlled by assessing the response to an IMP compared to an

active comparator or placebo or both. It is possible that a suspected adverse drug

reaction may occur in a participant receiving a comparator or indeed a placebo. If

this happens, the procedure is as follows.

If an adverse event is thought to be an adverse reaction, the investigator should

proceed on the assumption that the subject has received the test drug and report to

the sponsor accordingly.

Note that there is a requirement for the sponsor to report all SUSARs irrespective of

whether or not the participant has received the test drug. Therefore, if the unblinding

indicates that the suspect drug is an active comparator, the sponsor must report it as

a SUSAR in the light of its known side effect profile. The reporting mechanism is

exactly the same as for a test IMP. If on the other hand the adverse reaction is a


known reaction to the comparator, the event is reported as a SAR/SSAR in the

sponsor’s Annual Safety Report.

If the unblinding indicates that the suspect ‘drug’ is in fact a placebo, it should only be

reported by the sponsor as a SUSAR, if thought to be an unknown reaction to an

excipient compound (e.g. severe hypersensitivity reaction) in the placebo formulation.

THE DETAILED WRITTED REPORT OF THE ADVERSE EVENT/REACTION

A ‘Serious Adverse Event and Adverse Reaction Report’ pro-forma (the detailed

written report) is available for clinical trials for which NHS Tayside is acting as

Pharmacovigilance sponsor. See Appendix 3.

This form should be completed and returned to:

Pharmacovigilance Section

Research Development Services

Level 2, Residency Block

Ninewells Hospital & Medical School

A copy should be sent as an email attachment to:

[email protected]

For further information and advice concerning the reporting of adverse events and

adverse reactions to the sponsor, contact the Research Development Services Office

on 01382 660111, extension 33645

REPORTING BY SPONSOR TO MHRA AND THE ETHICS COMMITTEE

See page 1 of these guidelines for a definition of MHRA and Ethics Committee.

For most single site CTIMPs in Tayside, the Ethics Committee in question will be the

Tayside Committee on Medical Research Ethics A or B. Note that multicentre clinical

trials may also be reviewed ‘locally’ through the Fife & Forth Valley REC but, on

occasion, an alternative REC may be assigned via the NRES Central Allocation

System.


mailto:[email protected]

REPORTING SUSPECTED UNEXPECTED SERIOUS ADVERSE REACTIONS (SUSARs)

The sponsor is responsible for the expedited reporting of SUSARs to the MHRA and

the Ethics Committee.

Fatal or life-threatening SUSARs must be reported within 7 days of receipt of the

investigator’s report and other SUSARs within 15 days.

The current procedure is as follows.

The SUSAR report is contained within Part 2 of the detailed written report (see

Appendix 3). Alternatively the sponsor may transfer the relevant details in Part 2 of

the detailed written report to a CIOMS 1 Form which is available at

www.cioms.ch/cioms.pdf.

A copy should be sent by post to the Ethics Committee. Contact details for the

Tayside RECs and the Fife & Forth Valley REC are as follows.

AdministratorFife, Forth Valley & Tayside Research Ethics Service Office

Level 2, Residency BlockNinewells Hospital & Medical School

DundeeDD1 9SY

If another Ethics Committee provided the favourable ethical opinion (eg, if referred

via the Central Allocation System), the name and address of the Administrator can be

found at www.corec.org.uk. Select ‘REC Community’ then, from the menu bar, click

on ‘Contacts’ then ‘RECs’. Select by geographical location or alphabetical order.

Note that Administrators are described by COREC as ‘REC Co-ordinators’.

At present the MHRA will transfer all relevant data on SUSARs to the European

(EudraVIGILANCE) database in accordance with Part 5, 33(6) of the Regulations.

THE MHRA CONTACT DETAILS


http://www.corec.org.uk/

http://www.cioms.ch/cioms.pdf

These are available under Clinical trial authorisations: Safety reporting - SUSARS

and ASRs at:

www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Clinicaltrials/

Safetyreporting-SUSARSandASRs/index.htm

SUSARs are reported by submitting a paper copy of the detailed written report (Part

2 completed) or CIOMS 1 Form to which the relevant details have been transferred.

Reports may be scanned as PDF documents and e-mailed to

[email protected], clearly stating that the attachment is a UK

clinical trial SUSAR.

Paper UK clinical trial SUSAR reports should be sent to the MHRA’s centralised

scanning facility in Gloucester:

MHRA

PO Box 20

Mitcheldean

GL17 0WQ

There is also an existing fax facility for the reporting of UK SUSARs (020 7084 2443)

which, however, will eventually be phased out.

For non-UK clinical trials, SUSARs can be reported by submitting a paper copy of the

detailed written report (Part 2 completed) as follows:

By post to:

Clinical Trials Unit12-242MHRAMarket Towers1 Nine Elms LaneLondonSW8 5NQ

Or by fax to:0207 084 2443

INFORMING OTHER INVESTIGATORS


mailto:[email protected]

http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Clinicaltrials/Safetyreporting-SUSARSandASRs/index.htm

http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Clinicaltrials/Safetyreporting-SUSARSandASRs/index.htm

It is the sponsor’s duty to keep all other investigators undertaking clinical trials for

which they are also acting as sponsor informed of SUSARs where such trials also

involve the same IMP.

A standard letter template is available for this purpose, see ‘Notification of SUSAR by

Pharmacovigilance sponsor’, Appendix 5.

THE ANNUAL SAFETY REPORT

For a given study, the Pharmacovigilance sponsor must keep detailed records of all

SAEs, SARs and SUSARs that have been reported to them by the investigator(s)

and include them in an Annual Safety Report to MHRA and the Ethics Committee.

A template exists for this purpose, see Annual Report template, Appendix 4.


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