STANDARD OPERATING PROCEDURE FOR IDENTIFYING, … › admin › js › libs... · The sponsor pharmacovigilance procedure complies with the requirements of the Medicines for Human

The University of Dundee TASC SOP PV011v10.0 NHS Tayside Effective Date: 20/08/2018

Uncontrolled when printed. Please visit TASC Website

www.ahspartnership.org.uk/tasc/for-researchers/sops to guarantee adherence to the latest version of this SOP.

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STANDARD OPERATING PROCEDURE FOR IDENTIFYING, RECORDING AND

REPORTING ADVERSE EVENTS FOR CLINICAL RESEARCH

SOP NUMBER : TASC SOP PV011v10.0

AUTHOR: Kendra Tosoni

ISSUE DATE: 08 Aug 2018

EFFECTIVE DATE: 20 Aug 2018

REVIEW DATE: 20 Aug 2020

1 PURPOSE

This document describes the procedure for identifying, recording and reporting Adverse Events (AEs), Adverse Reactions (AR), Serious Adverse Events (SAEs), Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) occurring in Clinical Research Projects which are sponsored or co-sponsored by the University of Dundee (UoD) and/or NHS Tayside (NHST) where NHST has been delegated the responsibility for pharmacovigilance. For Clinical Trials of Investigational Medicinal products (CTIMPs), it also describes the procedure for updating the Reference Safety Information (RSI) and for Pregnancy reporting.

2 SCOPE

The sponsor pharmacovigilance procedure complies with the requirements of the Medicines for Human Use (Clinical Trial) Regulations 2004 and the European Pharmacovigilance Regulations (effective 2012) and subsequent amendments. Pharmacovigilance may be delegated to a third party but the process and reporting duties must be agreed between the Sponsor and third party before the trial commences with the responsibilities clearly documented. This SOP applies to members of staff associated with and managing research projects that are sponsored or co-sponsored by the UoD or NHST. Additionally, NHS Fife and NHS Forth Valley may use this SOP as and if applicable.

3 RESPONSIBILITIES

3.1 For CTIMPs:

Sponsor refers to TASC Pharmacovigilance Section ([email protected]).

- It is the Investigator’s (PI, CI or delegate) responsibility to report immediately serious adverse events and certain non-serious adverse events and/or laboratory abnormalities to the Sponsor.

- It is Sponsor responsibility to keep a record of all the notified adverse events. Moreover, Sponsor must notify SUSARs to the national competent authorities and the Research Ethics Committees and inform the Investigators.

3.2 For non-CTIMPs (including clinical investigations of medical devices):

Sponsor refers to TASC Research Governance Section ([email protected]).

- It is the Investigator’s (PI, CI or delegate) responsibility to report serious adverse events to the Research Ethics Committees and the Sponsor.The assessment of adverse events should be performed by a medically qualified doctor either PI or delegate. It’s also their responsibility to sign the forms where adverse events are recorded, to confirm their review.

http://www.tasc-research.org.uk/

http://www.tasc-research.org.uk/

http://www.ahspartnership.org.uk/tasc/for-researchers/sops

mailto:[email protected]




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4 PROCEDURE FOR CTIMPs

4.1 Adverse Events Reporting Flowchart




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4.2 Identifying, Classifying and Recording AEs and ARs in CTIMPs

4.2.1 In CTIMPs all test drugs used, including comparators are considered IMPs, and are subjected to safety reporting requirements. In some cases, non-Investigational Medicinal Products (non-IMPs) could be also subjected to reporting requirements, this should be detailed in the protocol.

4.2.2 The decision on what AE data to record should be the result of an assessment of the risk associated with the clinical trial.

4.2.3 The protocol should define how AEs and ARs will be identified, recorded and reported and also the time period.

4.2.4 AEs will be recorded from participant’s consent to take part in the trial until their last trial visit. Unless specified in the protocol, if a participant’s involvement in the trial has ended or the trial has ended, SAEs will not be actively sought but, if new SAEs are notified to the Investigator up to 30 days after last visit for that participant, they will require expedited reporting to Sponsor.

4.2.5 For the majority of trials, the Investigator(s), or a member of the research team with delegated responsibility (documented on the Delegation Log), should ask the trial participants at each trial visit about hospitalisations, consultations with other medical practitioners, disability or incapacity or whether any other AEs have occurred since the previous visit.

4.2.6 AEs may also be identified by support departments, for example, clinical biochemistry, haematology, and radiology. Where notification of such abnormal values or measurements would not occur as standard clinical practice, the procedure for notifying the Investigator must be clearly documented in the protocol or trial specific SOPs.

4.2.7 For the classification of AEs, please see below:

Adverse Event (AE)

Any untoward medical occurrence in a subject to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product.

Adverse Reaction (AR):

Any untoward and unintended response in a subject to an investigational medicinal product which is related to any dose administered to that participant.

Serious Adverse Event (AE), Serious Adverse Reaction (SAR) or Unexpected SAR:

any adverse event, adverse reaction or unexpected adverse reaction respectively that:

- Results in death; - Is life threatening; - Requires hospitalisation or prolongation of existing hospitalisation; - Results in persistent or significant disability or incapacity; - Consist of a congenital anomaly or birth defect; - Any important medical events which jeopardise the subject or require intervention

to prevent one of the above.

“Important medical events” may also be considered serious if they jeopardise the participant or require an intervention to prevent one of the above consequences. The term “life threatening“ in the definition of serious refers to an event in which the participant was at risk of death at the time of the event it does not refer to an event which hypothetically might have caused death if it were more serious.

Suspected Unexpected SAR:

A serious adverse reaction, the nature and severity of which is not consistent with the reference safety information about the medicinal product as listed in the IB or SmPC, as specified in the protocol (see also 4.14.2.)

4.2.8 Information on AEs should be recorded in source documents and added in the AE Log (Doc ref 086) and/or Case Report Form (CRF) (if applicable). Additionally, AEs and SAEs that will require expedited reporting will be recorded in the SAE forms (Doc ref 072).





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4.2.9 AEs and SAEs should be followed up, where feasible, until the outcome is resolved or resolved with sequelae. Otherwise the follow-up will be up to 30 days from last trial visit for that patient. When the participant has died or the continued follow-up of a research participant after their participation in the research has ended is not possible, the AE or SAE may be considered ongoing e.g. for a chronic condition.

4.3 Assessment of AEs

4.3.1 Reporting requirements for AEs in clinical trials are dependent on certain assessments, including seriousness, causality and expectedness.

4.3.2 Seriousness and causality must always be assessed by a medically qualified doctor (usually the Investigator) who has been delegated this task on the Delegation Log.

4.3.3 For randomised, double blind trials, AEs should be assessed as though the trial participant was taking the active study drug.

4.4 Seriousness assessment

4.4.1 The investigator should assess the AE based on the criteria defining SAEs and SARs in the table in section 4.2.7.

4.5 Severity assessment

4.5.1 The Investigator should assess the severity for all AEs using the following definitions:

Mild: a reaction that is easily tolerated by the trial participant, causing minimal discomfort and not interfering with everyday activities

Moderate: a reaction that is sufficiently discomforting to interfere with normal everyday activities and may warrant intervention

Severe: a reaction that prevents normal everyday activities or significantly affects clinical status and usually warrants intervention

Note: the term ‘severe’ used to describe the intensity of an event or reaction should not be confused with the term ‘serious’ which is a regulatory definition based on trial participant/event outcome action criteria. For example, a headache may be severe but not serious, while a minor stroke may be serious but is not severe

4.6 Causality assessment

4.6.1 The Investigator should assess the extent to which it is believed that the event may be related to the study drug, using the following definitions:

Unrelated: where the AE is not considered to be related to the study drug

Possibly: although a relationship to the study drug cannot be completely ruled out, the nature of the event, the underlying disease, concomitant medication or temporal relationship make other explanations more likely. Information on drug withdrawal may be lacking or unclear

Probably: the temporal relationship and absence of a more likely explanation suggest the event could be related to the study drug. Information on drug withdrawal may be available and if so the observed response to study drug withdrawal is considered clinically reasonable

Definitely: the known effects of the study drug or its therapeutic class, or based on challenge testing, suggest that the study drug is the most likely cause. Information on drug withdrawal is usually available and the observed response to study drug withdrawal is considered clinically reasonable and has a plausible temporal relationship to study drug exposure

4.6.2 All AEs judged to have a suspected causal relationship with the IMP (i.e. possibly, probably or definitely) will be considered as related to the IMP.

4.6.3 In CTIMPs using non-IMPs, any AE which is likely to be related to an interaction between the IMP and the non-IMP or where the AE may be linked to either the IMP or non-IMP but cannot be attributed to only one of these, must be considered as an AR.

4.6.4 The assessment of causality made by the Investigator cannot be downgraded by either the Chief Investigator or the Sponsor. In the case of a difference of opinion, both assessments should be recorded.





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4.7 Expectedness assessment

4.7.1 In case an AE/SAE is judged to be related to the study drug, the Investigator is required to assess expectedness based on the product information documented in the Reference Safety Information (RSI, see section 4.14 for more details).

Adverse Reactions may be classed as either:

Expected: the AR is consistent with the information on adverse effects of the study drug listed in the RSI. An expected AR must be an event previously observed and documented.

Unexpected: the AR is not consistent with the information on adverse effects of the study drug listed in the RSI.

4.7.2 An AR may be also described as ‘unexpected’ if it has occurred with greater frequency or severity that might otherwise have been expected.

4.7.3 For SARs, expectedness is also assigned by the Sponsor, following review of the RSI, and if different from the Investigator assessment, the Sponsors decision is considered final.

4.7.4 The RSI can change during the course of the trial: see section 4.14 for details.

4.8 Reporting SAEs, SARs and SUSARs by the Investigator to Sponsor

4.8.1 The identification of AEs and SAEs critical for the evaluation of the safety of the trial that the Investigator (or delegate) has to report to Sponsor, should be the result of an assessment of the risk associated with the clinical trial.

4.8.2 Certain serious adverse events could be deemed to be exempt from immediate reporting to the Sponsor (i.e. anticipated adverse events in the patient population or known adverse events of the IMP). This decision has to be clearly justified in the protocol. SAEs that are exempted from immediate reporting to Sponsor, should be recorded on the AE Log and line listing should be provided to Sponsor on request.

4.8.3 All non-serious AEs, SAEs, SARs and SUSARs that require immediate reporting should be reported by the Investigator (or delegate) to Sponsor, in writing, within 24 hours of becoming aware of the event.

4.8.4 SAE forms with details of such events must be send to Sponsor via email to [email protected]. Additional relevant information, not associated with the SAE reporting form e.g. separate files of data, should not be sent unless requested.

4.8.5 The SAE forms should be completed with as much information as possible. Assessment of causality, severity and expectedness should be provided by the Investigator (CI, PI or other medically qualified delegate), who will also have to sign and date the forms.

4.8.6 The blinding should be maintained unless it is considered in the interest of participant safety to unblind.

4.8.7 No participant identifiable information (other than date of birth, gender and study number) should be included on the SAE reporting form. If any is present, Sponsor will require that the study team amends the form before sending it for clinical review.

4.8.8 If at the time of reporting some of the information required is not available, the Investigator must ensure that this is provided as soon as this becomes available. The SAE reporting form should indicate that this information constitutes a follow-up of a previously reported event.

4.8.9 Copies of all SAE reporting forms sent to Sponsor must be retained by the Investigator in the Trial Master File (TMF) or Investigator Site File (ISF).

4.8.10 Members of study teams with delegated function of safety reporting, must be fully trained on the AE reporting requirements.

4.8.11 The information recorded for SAEs in the CRF and clinical database should match the information on the SAE Form sent to the Sponsor and will be reconciled at the end of the trial, prior to database lock.






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4.9 Expedited reporting of other events by the Investigator to Sponsor

4.9.1 The following safety issues should also be reported by the investigator to the sponsor in an expedited fashion:

An increase in the rate of occurrence or a qualitative change of expected SAR, which is judged to be clinically important.

Post-study SUSARs that occur after the patient has completed the trial and are reported to the investigator.

Recommendations of the Data Monitoring Committee, where relevant for the safety of trial participants.

New events related to the trial or the development of the IMP which are likely to affect the safety of the participants (i.e. SAEs which could be associated with the trial procedures and which could modify the conduct of the trial; a significant hazard to the patient population, such as lack of efficacy of an IMP used to treat a life-threatening condition; a major safety finding from a newly complete animal study (i.e. carcinogenicity)).

4.9.2 The Sponsor is responsible for informing the MHRA and the REC of these safety issues.

4.9.3 A copy of all correspondence should be kept in the TMF, ISF (if applicable) and sponsor file.

4.10 Expedited reporting of SUSARs by the Sponsor

4.10.1 The Sponsor is responsible for reporting SUSARs to the National Competent Authorities which approved the study and to the Research Ethics Committee (REC) which provided a favourable ethical opinion.

4.10.2 For trials taking place only in the UK this means:

- Reporting to the MHRA all UK-relevant SUSARs (using either MHRA’s eSUSAR website or EudraVigilance);

- Reporting to the UK REC using the CTIMPs Safety Report Form (available from the Health Research Authority (HRA) website) and providing a copy of the submitted SUSAR report.

For trials conducted also in other states of the European Economic Area this means:

- Reporting to the competent authorities of all the countries where the trial is taking place (using EudraVigilance);

- Reporting to the local REC as per their procedures.

4.10.3 The Sponsor can delegate these pharmacovigilance tasks to National Coordinator centres or third parties, as appropriate.

4.10.4 The timeframe for reporting is the following:

- SUSARs that are fatal or life-threatening must be reported within 7 calendar days of Sponsor’s receipt of the Investigator’s report. Relevant follow-up information must be communicated within 8 calendar days from initial submission.

- Other non-fatal or life-threatening SUSARs must be reported within 15 calendar days. Relevant follow-up to be communicated within the 15 days’ timeframe (or 7 days if fatal or life-threatening)

The day of receipt by Sponsor of the information (either initial notification or follow-up) is assigned Day 0.

4.10.5 Only unblinded SUSARs should be reported by the Sponsor. Investigators should only receive blinded information unless unblinding is necessary for safety reasons. All paperwork related to unblinded SUSARs should be filed in a sealed envelope in the Sponsor file but not held in the TMF.

4.10.6 SUSARs associated with comparators follow the same reporting requirements as for the test IMP. Events associated with placebos usually do not satisfy the criteria for expedited





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reporting unless an association can be made i.e. to an excipient or impurity; in this case a SUSAR should be reported.

4.10.7 Investigators and Sponsor are encouraged to report unexpected serious adverse reactions related to non-IMPs that are marketed medicinal products, to competent authorities or marketing authorisation holders.

4.10.8 The Sponsor is required to inform all investigators, in a timely manner, of SUSARs that occur in relation to an IMP used in trials in which they are involved.

4.10.9 Reports sent to an Investigator regarding SUSARs from other trials of the same medicinal product must be reviewed by the Investigator and acted upon if appropriate. Copies of such SUSAR reports must be kept in the TMF or ISF.

4.11 Urgent Safety Measures

4.11.1 The Sponsor and Investigator may take appropriate urgent safety measures to protect the participants of a CTIMP against any immediate hazard to their health or safety.

4.11.2 Urgent safety measures can be implemented immediately without seeking approval. 4.11.3 The Investigator should phone the Clinical Trial Unit at the MHRA and discuss the issue

with a Safety Scientist immediately. The Sponsor and the REC should also be contacted by phone at this time.

4.11.4 The Investigator must notify the MHRA and the REC in writing in the form of a Substantial Amendment within 3 days. This notification should include a covering letter detailing the measures taken, the reason for them, the Substantial Amendment form and any supporting documentation.

4.12 Other reporting requirements

4.12.1 The Sponsor is responsible for the preparation (jointly with the CI) and the content of the Development Safety Update Report (DSUR). The DSUR is submitted by the Sponsor to MHRA (or other national competent authorities) and REC within 60 days from the anniversary of the Clinical Trial Authorisation (or the International Birth Date (IBD) of the IMP, if this is used).

4.12.2 The CI is responsible for submitting the Annual Progress Report to the REC. This is due on the anniversary of the first REC approval plus 30 days.

4.12.3 DSUR and Annual Progress Reports are due each year, until the End of Trial Declaration has been sent.

4.13 Pregnancy reporting

4.13.1 Pregnancy is not considered an AE or SAE, however an abnormal outcome would be. For this reason, the Investigator must collect pregnancy information for female trial participants or female partners of male trial participants who become pregnant while participating in a study.

4.13.2 For female partners of male trial participants who become pregnant while participating in a study, consent should be obtained to follow up the pregnancy.

4.13.3 The Investigator should record the information on a Pregnancy Notification Form (Doc Ref 058a) and send this to Sponsor within 14 days of being made aware of the pregnancy.

4.13.4 Any pregnancy that occurs in a trial participant or a trial participant’s partner during a trial should be followed to outcome. In some circumstances, it may be necessary to monitor the development of the new-born for an appropriate period post-delivery. Follow up information should be recorded on the Pregnancy Follow Up Form (Doc Ref 058b) and sent to Sponsor.





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4.14 Reference Safety Information (RSI)

4.14.1 The RSI includes a list of all observed related adverse reactions, serious and non-serious, including a description of the nature of events, severity or grade as well as their frequency. It should be clearly identified in the protocol.

4.14.2 The RSI of an IMP: - Without marketing authorization (MA) in the EU should be a clearly specific and

separated section within the Investigator’s Brochure (IB); - With a MA in the EU should be the section 4.8. ‘Undesirable Effects’ of the

appropriate SmPC; If the IMP has a MA in several Member States concerned with different SmPCs, the sponsor should justify its selection of the most appropriate to use as source for the RSI.

4.14.3 Only the RSI approved by a national competent authority can be implemented during the study: the RSI approved with the clinical trial authorisation (CTA) can only be changed via submission of a substantial amendment.

4.14.4 For the purpose of expectedness assessment, Investigators should use the RSI contained in the SmPC (or IB) version which has been approved at the time of the event.

4.14.5 The Investigator is responsible for checking if any changes have been made to the RSI that have an impact risk/benefit of the trial (i.e. the addition of new events). The advice is to check at least 2 months before CTA anniversary.

4.14.6 If changes have been made and are significant and/or are relevant to the study or patient population, the Investigator has to make risk assessment of how those changes affect the RSI. The outcome can be:

- To continue to use the old version of the RSI: the Investigator has to document the risk assessment for all the changes of the RSI and this documents has to be reviewed and approved by an independent specialist clinician;

- To change the RSI: this requires the submission of a substantial amendment. The implementation of the new RSI will start only after approval by the competent authority and will be simultaneous with the start of a new reporting period of the DSUR (if this implies that for a period after approval the old version will still be in use, this has to be documented and stated in the amendment request).




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5 PROCEDURE for non-CTIMPs (including clinical investigations of medical devices)

5.1 Adverse Events Reporting Flowchart





.

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5.2 Identifying AEs

5.2.1 The research protocol should give indications on how AEs will be identified, what data will be recorded and which events of an expected occurrence that will be excluded from reporting.

5.2.2 As a general practice, participants should be asked about AEs and SAEs at each study visit, and all events must be logged in the CRF and/or in the AE Log (as appropriate).

5.3 Reporting SAEs

5.3.1 Only SAEs occurring to a research participant must be reported to REC and to

Sponsor if, in the opinion of the Chief Investigator (CI) they are:

- Related to the study: i.e. it resulted from administration of any of the research procedures;

- Unexpected: the type of event is not listed in the protocol as an expected occurrence.

5.3.2 Unless specified in the protocol, if a participant’s involvement in the trial has ended or the trial has ended, SAEs will not be actively sought but, if new SAEs are notified to the Investigator up to 30 days after LPLV for that participant, they will have to be reported.

5.3.3 Reports on these SAEs must be submitted to REC within 15 calendar days of the Investigator becoming aware of the event, and copied to the Sponsor via email to [email protected].

5.3.4 The report form to be used is the non-CTIMP Safety report to REC form that can be found on the HRA website.

5.3.5 Reports of SAEs in double-blind trials should be unblinded prior to report. Unblinding should be performed by the RGM or delegate.

5.3.6 The TASC RGM will contact the CI, and any other pertinent party, to discuss an SAE Report, if necessary.

5.3.7 REC will acknowledge the receipt of the Report by returning the Signed original form to the CI, or other person submitting report.

5.3.8 All SAE Reports must be maintained in the TMF/SMF and ISF, where appropriate together with any communication with REC and Sponsor.

5.3.9 The CI should include a report on the safety of participants in each Annual Progress Report. There is no requirement for an annual safety report in addition to the information provided through the annual progress report.

5.4 Urgent Safety Measures

5.4.1 Urgent safety measures can be taken immediately by the CI or the Sponsor, or exceptionally and where necessary, by a Site PI.

5.4.2 The CI must notify REC and Sponsor (i) immediately by telephone and subsequently (ii) in writing 3 days, in the form of a substantial amendment, setting out the reason(s) for the urgent safety measures and the plan for further action.

5.4.3 The REC Manager will acknowledge receipt of this communication within 30 days.





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6 ABBREVIATIONS & DEFINITIONS

AE Adverse Event AR Adverse Reaction CI Chief Investigator CRF Case Report Form CTIMP Clinical Trial of an Investigational Medicinal Product DSUR Development Safety Update Report GCP Good Clinical Practice IB Investigators Brochure IMP Investigational Medicinal Product ISF Investigator Site File MHRA Medicines and Healthcare products Regulatory Agency NRES National Research Ethics Service NIMP Non Investigational Medicinal Product NHST NHS Tayside REC Research Ethics Committee RSI Reference Safety Information SAE Serious Adverse Event SAR Serious Adverse Reaction SUSAR Suspected Unexpected Serious Adverse Reaction SmPC Summary of Product Characteristics SOP Standard Operating Procedure TCTU Tayside Clinical Trials Unit TMF Trial Master File UoD University of Dundee

7 ASSOCIATED DOCUMENTS & REFERENCES

Doc Ref 058a: Pregnancy Notification Form Doc Ref 058b: Pregnancy Follow Up Form Doc Ref 072: Serious Adverse Event Form Doc Ref 086: Adverse Event Log WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human Subjects. Medicines for Human Use (Clinical Trials) Regulations 2004. It is assumed that by referencing the principal regulations, all subsequent amendments made to the principal regulations are included in this citation.

8 DOCUMENT HISTORY

Version Number:

Edited by (job title): Effective Date:

Details of editions made:

1.0 Violet Warwick (Clinical Trials Monitor) Gus MacConnachie (Medical Scientific

01/11/2008 New.





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Advisor) David Martin (Pharmacovigilance Monitor)

2.0 Shaun Treweek (chair of CRGC)

1/1/2009

Update of authors. Updated terms used to describe agreements so that they have a consistent format (‘Clinical trial XX agreement’, where XX is ‘site’, ‘CI’ etc).

3.0 Violet Warwick (Clinical Trials Monitor)

05/08/2009 Bringing the document into line with the prevailing NHS Tayside Guidelines on Pharmaco-vigilance in Clinical Trials of Investigational Medicinal Product.

4.0 Louise Boldy (Governance & Safety Manager) David Martin (PV Monitor)

01/12/2010 Update to reflect changes in AE reporting procedures within TASC.

5.0 Louise Boldy (Governance & Safety Manager)

07/03/2011 Original authors reinstated. Addition of urgent safety measures section and AE log reference number and update of typographical errors.


12/09/2011 Addition of procedural flowchart, clarification on participant identifiable data required on the SAE reporting form and the addition of the requirement to unblind SUSARs before reporting.


12/09/2013 Standardisation of PV Monitor, TASC office and Sponsor to TASC Pharmacovigilance. AE and AR definitions added to section 4.2.2. Addition of substantial amendment form to section 4.9.3. Abbreviations list updated.

8.0 Anna Barnett (Clinical Trials Operations Manager)

12/09/2015 Expansion of text in sections 4.6, 4.7 4.8 and 4.9 Addition of a reference (European Pharmacovigilance Regulations).

9.0 Valerie Godfrey (Quality Assurance Manager )

12/09/2017 Changes to sections 4.2, 4.3, 4.8 and 4.9 to reflect current process.

10.0 Kendra Tosoni (Pharmacovigilance Monitor)

20/08/2018 New TASC SOP format implemented. Title, text and flowchart amended to cover all types of Clinical Research. New section (4.14) on Reference Safety Information (RSI) added.


Documents

STANDARD OPERATING PROCEDURE FOR IDENTIFYING, … › admin › js › libs... · The sponsor pharmacovigilance procedure complies with the requirements of the Medicines for Human