STANDARD OPERATING PROCEDURE

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1 STANDARD OPERATING PROCEDURE Title Reference Number Adverse Event Identification, Recording and Reporting in Clinical Trials of Investigational Medicinal SOP-RES-019 Version Number 2 Issue Date 08 th Dec 2015 Effective Date 22 nd January 2016 Review Date 22 nd January 2018 Author(s) Reviewer(s) Teresa O Leary, Head of Regulatory Compliance (Interim) Melanie Boulter, QA Auditor Authorisation (Original signatures are retained by Research & Innovation) Dr Brian Thomson Director of Research & Innovation Dr Stephen Fowlie Medical Director 24 th Nov th Dec 2015 USERS OF THIS STANDARD OPERATING PROCEDURE MUST REFER TO TO ENSURE THE MOST CURRENT VERSION IS BEING USED

2 Page 2 of Document History Version Number Issue Date Reason for Change 1 22 nd April 2014 Original SOP. It replaces SOP th Dec 2015 Updated to include information regarding electronic incident reporting and the Duty of Candour. Updated based on CAPA CA1503.

3 Page 3 of Introduction It is essential to collect, assess and report information on the adverse effects of medicines and research procedures. To comply with The Medicines for Human Use (Clinical Trials) Regulations 2004 and International Conference on Harmonisation Guidelines for Good Clinical Practice (ICH-GCP) it is important that all researchers are aware of the different definitions of adverse events (AEs) in research and how to record, report and review each of these specific occurrences. All AEs that occur during the course of a trial must be recorded and those of a serious nature, reported appropriately in order to ensure that patient safety is maintained. The Medicines for Human Use (Clinical Trials) Regulations 2004 apply to adverse event reporting requirements for all clinical trials of investigational medicinal products (CTIMPs). Non-CTIMP studies also have specific adverse event reporting requirements but they do not fall under these regulations. Failure to comply with AE reporting requirements constitutes a serious breach and can result in the withdrawal of approval for the research, or, in significant cases, prohibition of research conducted by an individual investigator or an organisation. 3. Purpose and Scope This standard operating procedure (SOP) describes the process for identifying, recording and reporting AEs for CTIMPs that are sponsored by Nottingham University Hospitals NHS Trust (NUH) and applies to all personnel involved in the conduct of NUH sponsored research. This SOP does not describe the AE recording and reporting process for externally sponsored CTIMPs hosted by NUH. NUH personnel involved in the conduct of externally sponsored research must follow sponsor procedures for individual studies. However, NUH staffs are required to report events through Datix, refer to section Responsibilities All Research Staff For NUH sponsored CTIMPs, any researcher who is delegated AE recording and reporting duties on the delegation log must comply with this SOP. For hosted studies, the researcher delegated this responsibility should also ensure, where appropriate, the AE is reported via

4 Page 4 of 18 the NUH Datix system if the event has occurred at NUH (refer to the NUH NHS Trust - Incidents Reporting Policy and Procedures Manual 2009). Chief Investigator (CI) Responsible for discussing AE information with researchers, including for multi-site CTIMPs, in accordance with this SOP. Sponsor (fulfilled by the Research and Innovation (R&I) department on behalf of NUH) Responsible for ensuring an independent assessment of AEs is performed as required, and that any AEs that require expedited reporting are reported to the Medicines and Healthcare products Regulatory Agency (MHRA) and the Research Ethics Committee (REC) appropriately, and disseminated to all researchers in multi-site CTIMPs. The sponsor is also responsible for the registration of the study on the MHRA electronic SUSAR reporting site (esusar).

5 Page 5 of Definitions and Abbreviations Adverse Event An adverse event (AE) is any untoward medical occurrence including occurrences which are not necessarily caused by or related to the investigational product. An AE can therefore be any unfavourable and unintended sign (including abnormal laboratory results), symptom or disease temporarily associated with the use of the medicinal product, whether or not considered to be related to the medicinal product. An AE is not always an adverse reaction (AR). Adverse Reaction An AR is any untoward and unintended response in a participant to an investigational medicinal product (IMP) which is related to any dose administered to that participant. Any AE judged by either the reporting investigator or the sponsor as having reasonable causal relationship to an IMP qualifies as an AR. Therefore an AR is always considered an AE. Unexpected Adverse Reaction An unexpected adverse reaction is an AR, the nature or severity of which is not consistent with the applicable product information (i.e. the investigator's brochure (IB) for an unapproved IMP or the summary of product characteristics (SmPC or SPC) for an IMP with a marketing authorisation). Serious Adverse Event or Serious Adverse Reaction A serious adverse event (SAE) or serious adverse reaction (SAR) is any untoward medical occurrence that: results in death is life-threatening * requires inpatient hospitalisation or prolongation of existing hospitalisation results in persistent or significant disability/incapacity consists of a congenital anomaly or birth defect. An important medical event that jeopardises the participant or requires an intervention to prevent one of the above consequences should also be considered serious. * 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 severe. Medical judgement should be exercised in deciding whether an SAE/SAR is serious in other situations.

6 Page 6 of 18 A planned hospitalisation or outpatient treatment is not considered to be an SAE Suspected Unexpected Serious Adverse Reaction A suspected unexpected serious adverse reaction (SUSAR) is a SAR, the nature and severity of which is not consistent with the reference safety information (RSI) (i.e. the IB for an unapproved IMP or the SmPC/SPC for an IMP with a marketing authorisation). A SUSAR can only be confirmed as such once the blind has been broken and the event is verified as an SAR and not an SAE. Investigational Medicinal Product An IMP is a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form. Non-Investigational Medicinal Product A non-investigational medicinal product (NIMP) is a medicinal product which is not the object of investigation in a clinical study (i.e. not the tested product, placebo or active comparator) but is supplied to participants in a clinical trial and used in accordance with the protocol. This might be, for example, medicinal products such as support/rescue medication for preventative, diagnostic or therapeutic reasons and/or to ensure that adequate medical care is provided for the participant. These medicinal products do not fall within the definition of IMPs in Directive 2001/20/EC. NIMPs used in the trial may also be subject to reporting requirements and details should be provided in the trial protocol. Reference Safety Information The reference safety information (RSI) is used when assessing if an adverse reaction is expected. For a trial involving an unapproved IMP any adverse reactions known to be related to the IMP will be listed in the Investigators Brochure (IB). For a trial involving an IMP with a marketing authorisation any adverse reactions known to be related to the IMP will be listed in the SmPC/SPC.

7 Page 7 of 18 AE AR CI CRF CTIMP CQC IB ICH-GCP IMP ISF MAH MHRA NHS NHSP NIMP NUH PI PV QA QMC R&D R&I REC Researcher RPM RSI SAE SAR SmPC / SPC SOP SUSAR TMF Working Day Adverse Event Adverse Reaction Chief Investigator Case Report Form Clinical Trial of an Investigational Medicinal Product Care Quality Commission Investigator Brochure International Conference on Harmonisation Guidelines for Good Clinical Practice Investigational Medicinal Product Investigator Site File Marketing Authorisation Holder Medicines and Healthcare products Regulatory Agency National Health Service Nottingham Health Science Partners Non-Investigational Medicinal Product Nottingham University Hospitals NHS Trust Principal Investigator Pharmacovigilance Quality Assurance Queen s Medical Centre Research and Development Research and Innovation Research Ethics Committee Any member of the research team identified on the trial delegation log to perform trial-specific activities Research Project Manager Reference Safety Information (e.g. IB or SmPC) Serious Adverse Event Serious Adverse Reaction Summary of Product Characteristics Standard Operating Procedure Suspected Unexpected Serious Adverse Reaction Trial Master File Normal operating hours of 09:00h to 17:00h on days Monday to Friday, excluding bank holidays

8 Page 8 of Procedure 6.1 Identification, Recording and Reporting Adverse Events of CTIMPs The research site must protect the dignity, rights, safety and well-being of participants as a priority at all times. The Investigator (or other delegated researcher) must identify if an AE has occurred, as defined by the protocol. This is usually achieved through discussion with the participant during trial visits, but may also be identified if the researcher reviews the participant s medical records or is informed by the participant s relative, carer, another clinician or support department of an occurrence that would constitute such an event. If an AE has occurred the Investigator (or other delegated researcher) must review all relevant documentation (e.g. medical notes, laboratory results and diagnostic reports). The Investigator (i.e. medically qualified researcher) will assess the intensity, causality, expectedness and seriousness of the event as described in section 6.2. Unless stated otherwise in the protocol, all AEs must be recorded in detail. The research site must record all AEs using the Adverse Events Record (TAFR01901) and retain it with the participant s Case Report Form (CRF), unless an AE record is incorporated into the CRF design and agreed by the Sponsor in which case this must be completed. The AE, including its severity, cause and seriousness, must also be recorded in the participant s medical notes by the Investigator (or other delegated researcher). The CI (or Principal Investigator (PI) in multi-centre research) must review all recorded AEs at their site, and this must be documented on the Adverse Events Record (TAFR01901) and made available to the Sponsor on request. AEs and/or laboratory abnormalities defined in the protocol as critical to the evaluation of safety shall be reported to the Sponsor by the research site in accordance with the reporting requirements detailed in the protocol. 6.2 Assessment of AEs Each AE must be assessed for seriousness, causality, severity and expectedness. It is the Investigator(s) responsibility to assess each AE. This may be delegated to other suitably qualified physicians in the research team who are trained in recording and reporting AEs. For randomised double blind studies, AEs should be assessed as though the trial participant was taking the IMP.

9 Page 9 of Assessment of Seriousness The Investigator should make an assessment of seriousness as defined in section Assessment of Causality The Investigator should make an assessment of whether the AE is likely to be related to the IMP according to the following definitions:- Unrelated: where an event is not considered to be related to the IMP. Possibly: although a relationship to the IMP cannot be completely ruled out, the nature of the event, the underlying disease, concomitant medication or temporal relationship make other explanations possible. Probably: the temporal relationship and absence of a more likely explanation suggest the event could be related to the IMP. Definitely: the known effects of the IMP or its therapeutic class, or based on challenge testing, suggest that the study drug is the most likely cause. All AEs judged as having a reasonable suspected causal relationship to the IMP (i.e. possibly, probably, definitely) will be considered as related to the IMP. In trials using NIMPs the Investigator must also consider whether the AE is likely to be related to an interaction between the IMP and the NIMP, or whether the AE might be linked to either the IMP or the NIMP but cannot be clearly attributed to either one of these. Any AE that is considered to be related to the IMP, or an interaction between the IMP and NIMP, or cannot be clearly attributed to either one of these is described as an Adverse Reaction (AR). Where there are two assessments of causality, for example, the Investigator and the Sponsor assessment, or the CI and Investigator assessment, the causality made by the Investigator cannot be downgraded. In the case of a difference of opinion, both assessments are recorded and the most conservative assessment is used for reporting purposes. However, if the Sponsor s disagrees with the investigators causality assessment then both opinions should be reported and fully documented Assessment of Severity The Investigator should make an assessment of severity for each AE and this should be recorded on the CRF or AE form according to the following categories: Mild: an event that is easily tolerated by the trial participant, causing minimal discomfort and not interfering with every day activities.

10 Page 10 of 18 Moderate: an event that is sufficiently discomforting to interfere with normal everyday activities. Severe: an event that prevents normal everyday activities. The term severe used to describe the intensity of an event 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 Assessment of Expectedness If the AE is judged to be related to the IMP (as described in 6.2.2), the Investigator should make an assessment of expectedness based on knowledge of the AR and any relevant product information as documented in the IB or the SmPC. The event should be classed as either; Expected: the AR is consistent with the toxicity of the study drug listed in the SmPC or IB. Unexpected: the AR is not consistent with the toxicity in the SmPC or the IB. 6.3 Recording and Reporting Serious Adverse Events If the research site determines that an AE fulfils one of the seriousness criteria (as defined in the protocol and GCP) the Investigator (or other delegated researcher) must report the SAE to NUH R&I within 24 hours of becoming aware of it. The only exception to this is where the protocol identifies the event as not requiring immediate reporting. The SAE must be recorded on the Serious Adverse Events Log (TAFR01902) and retained in the ISF. The research site must report the SAE to R&I in writing using the Serious Adverse Event Reporting Form (CTIMP) (TAFR01903), providing as much information as possible. The reporting form must be completed legibly ensuring that names, dates, and descriptions are clear and that abbreviations have not been used. For details of definitions required in the SAE reporting form, refer to section 6.2. The SAE may be reported verbally (but not by voic ) in circumstances where a written report is not immediately possible; however this must be followed by a written report the next working day. SAE reports must be retained in the ISF. If the SAE is not related to the IMP but is related to a trial procedure, this must also be reported to R&I in writing using the Serious Adverse Event Reporting Form (CTIMP) (TAFR01903). The CI (or PI in multi-centre research) must review and sign all SAE reports. In the event the CI/PI is unable to sign the report immediately the research site must not delay

11 Page 11 of 18 sending the report to R&I, however a CI/PI signed copy must be forwarded to R&I as soon as possible. The SAE form must be completed in full, entering N/A for questions which are not relevant. SAE reports must be sent to R&I using one of the following methods: i. ii. Hand delivered not mailed (R&I, NHSP, C Floor, South Block, QMC) iii. Telephone ( ) if written report not immediately possible The R&I Administrator will check the group inbox and mail tray twice daily and sign a log to verify the check has been completed (TAFR02804). For hand delivered SAE reports the CI/PI (or delegate) must record the date and time the SAE was reported in the Additional Comments section of the Serious Adverse Event Reporting Form (CTIMP) (TAFR01903) and/or Pregnancy Reporting Form (TAFR01905). For telephone reporting of SAEs: o R&I representative must complete a Serious Adverse Event Reporting Form (CTIMP) (TAFR01903) with the details provided. In the Additional Comments section, the R&I representative must record who received the call, date and time of the telephone call. The SAE form must then be reported to the Head of Regulatory compliance or compliance RPM(s) immediately for further processing. o The CI/PI (or delegate) who telephones in an SAE must follow-up and complete a Serious Adverse Event Reporting Form (CTIMP) (TAFR01903) and send the form to R&I via or hand delivery. The R&I RPM will collate and reconcile both SAE forms. The R&I RPM will check the SAE report for completeness, assign the SAE a unique reference number and ensure it is documented within the Serious Adverse Events Tracker (TAFR01907). The R&I RPM will send confirmation of receipt of the SAE report and its unique reference to the research site within 1 working day. Any omitted information or discrepancies will be requested from the research site. The research site must telephone R&I ( ) if the SAE reference number and confirmation of receipt is not received within 1 working day of sending the SAE report. The research site must provide any information omitted from the initial SAE report to R&I within 5 working days. The R&I RPM will facilitate an independent assessment of the event within 1 working day of receiving the SAE report. The independent assessment for causality and expectedness of the SAE will be performed by the Sponsor s Medical Monitor within 24 business hours of their receipt,

12 Page 12 of 18 using the protocol, IB or SmPC as the Reference Safety Information (RSI) for expected events. The Medical Monitor will return the completed assessment to the R&I RPM. The R&I RPM will provide the CI with details of the SAE (if not already aware), update the Serious Adverse Events Tracker (TAFR01907) and retain all SAE documentation in the Trial Master File (TMF). The research site must send SAE follow up information to R&I as soon as new information becomes available using the Serious Adverse Event Follow Up Reporting Form (CTIMP) (TAFR01904) using one of the reporting methods described in 6.3 point 6. Follow up documentation must be retained in the ISF with the original SAE documentation. The R&I RPM will provide a copy of the SAE follow up report to the Sponsor s Medical Monitor and the CI (if not already aware), update the Serious Adverse Events Tracker (TARF01907) and retain the follow up documentation with the original SAE documentation in the TMF within R&I. 6.4 Reporting Suspected Unexpected Serious Adverse Reactions (SUSARs) If the Sponsor s Medical Monitor considers an SAE to be treatment-related and also unexpected i.e. inconsistent with the RSI, they will inform the R&I RPM, who will notify the CI and the R&I Head of Regulatory Compliance on the same day. Refer to Appendix 2. If the trial is blinded and an SAE is assessed as a SUSAR, the Sponsor procedure (SOP-RES-023 Managing the Code-Break and Unblinding ) for unblinding and the protocol unblinding instructions must be followed. If unblinding confirms the participant received the investigational product or comparator product, the event is confirmed as a SUSAR. If unblinding confirms the participant did not receive the investigational product or comparator product (i.e. they received the placebo) this will not require expedited reporting unless, in the opinion of the Medical Monitor, CI or the Sponsor, the event was a reaction to a component of the placebo. The CI and the Sponsor must determine if any action taken by the research site in response to the SUSAR is appropriate or an urgent safety measure is required (refer to SOP-RES-022 Urgent Safety Measures ). The R&I RPM will be responsible for expedited reporting of the SUSAR to the MHRA (via esusar) and to the REC that granted study approval. Fatal or life-threatening SUSARs must be reported by the R&I RPM within 7 days of the Sponsor becoming aware of the event, with any further information reported within an additional 8 days. SUSARs which are not assessed as fatal or life threatening must be reported by the R&I RPM within 15 days of the Sponsor becoming aware of the event.

13 Page 13 of 18 If significant new information on an already reported SUSAR is received by the Sponsor it must be reported as a follow-up report to the MHRA and the REC by the R&I RPM within 15 days. The R&I RPM will disseminate SUSAR information to the CIs and PIs of any trial involving the IMP and retain a record of this in the TMFs. The CIs should notify their trial committee(s) accordingly. For blinded studies, and in order to maintain the blind, the RPM will notify the CIs and PIs that the unblinded SUSAR was reported and will not disseminate unblinded information to the research team(s). PIs should notify their Research and Development (R&D) department of the SUSAR, according to local procedures. The R&I RPM is responsible for reporting SUSARs identified after the end of the trial to the MHRA and the REC. 6.5 Follow Up of Adverse Events The research site must follow up all on-going AEs to resolution, until the participant exits the trial or, if in the opinion of the CI/PI, the AE requires no further follow up. This will be defined by the protocol. A file note explaining the reason should be entered in the site file. AE follow up activity must be documented in the CRF by the CI/PI. The CI/PI does not need to actively monitor subjects for AEs once the trial has ended, unless provided otherwise in the protocol. If the research site becomes aware of an SAE after the participant s treatment has ended this must also be reported to the Sponsor as described in 6.3 point 6. The CI is responsible for informing the Sponsor and PIs of relevant information about AEs that could affect the participants safety. If urgent safety measures are required SOP-RES-022 Urgent Safety Measures must be followed. 6.6 Reporting a Pregnancy While not considered an AE or SAE, the CI/PI (or other delegated researcher) must notify the Sponsor if a participant, or a female partner of a male participant, in a trial becomes pregnant; this procedure must be defined in the protocol. This must be reported using the Pregnancy Reporting Form (TAFR01905) and sent to R&I (as described in 6.3 point 6) within 14 days of the research site becoming aware of the pregnancy. The research site must report any pregnancy that results in an SAE (such as congenital anomaly or birth defect) to the Sponsor as described in 6.3 point 6.

14 Page 14 of 18 The R&I RPM will track the pregnancy to ensure timely follow up is performed by the research site, and notify the Head of Regulatory Compliance. The research site should follow a pregnancy to its end whether this results in a live birth, still birth, miscarriage or abortion, provided the appropriate informed consent has been obtained to collect follow up information. In some circumstances, it may be necessary to monitor the development of the newborn for an appropriate period postdelivery. A Pregnancy Follow Up Reporting Form (TAFR01906) must be completed and sent to R&I (as described in 6.3 point 6). The R&I RPM will report the pregnancy to the marketing authorisation holder (MAH) (for trials using a licensed IMP) or to the MHRA (for trials using an unlicensed IMP) within 15 days of receiving the initial pregnancy report. 6.7 Datix If the reporting investigator considers an SAE to be treatment-related, the event is judged to be SAR, or SUSAR depending on the information provided in the RSI. An SAR which occurs within NUH, must be reported on the Trusts electronic incident reporting system, Datix. Any ARs judged to be SUSARs which have occurred within NUH, must also be reported on Datix, as well as to the Sponsor of the trial. Reporting of incidents on Datix must be carried out in accordance with the Trust s Incident Reporting Policy and Procedures Manual. 6.8 Duty of Candour Duty of Candour is a new statutory requirement which applies to all providers (including NUH) registered with the CQC. Duty of Candour was recommended following the Mid-Staffordshire inquiry and was transposed into law to ensure openness and transparency with patients when an incident surrounding their care has occurred. All incidents which have been entered onto Datix (see 6.7) as moderate, severe or death (where the death relates directly to the incident) will be required to follow the Duty of Candour process. The requirement ensures that the appropriate information surrounding the incident is disseminated to patients, their relatives and carers. The Duty of Candour Trust SOP and flowchart should be followed for such events by formally following any information up in writing, should the patient, relative or carer request this.

15 Page 15 of References and Associated Documents The Implementation of Good Clinical Practice in the Conduct of Clinical Trials on Medicinal for Human Use (Directive 2001/20/EC) EudraLex - Volume 10 Clinical trials guidelines: Detailed Guidance on the Collection, Verification and Presentation of Adverse Event/Reaction Reports Arising from Clinical Trials on Medicinal for Human Use ( CT-3 ); and Guidance on Investigational Medicinal (IMPs) and Non-Investigational Medicinal (NIMPs) (Rev. 1, March 2011) The Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments International Conference on Harmonisation Guidelines for Good Clinical Practice E6 (R1) International Conference on Harmonisation Guidelines for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting E2A Good Clinical Practice Guide Compiled by the Medicines and Healthcare products Regulatory Agency, published 2012 Incident Reporting Policy and Procedures Manual 2015 NUH Being Open Policy and Procedure (GG/CG/003) SOP-RES-002 SOP-RES-010 SOP-RES-011 SOP-RES-022 SOP-RES-023 TAFR01901 TAFR01902 TAFR01903 TAFR01904 TAFR01905 TAFR01906 TAFR01907 Risk Assessment Site Initiation Regulatory Green Light Urgent Safety Measures Managing the Code-Break and Unblinding Adverse Events Record Serious Adverse Events Log Serious Adverse Event Reporting Form (CTIMP) Serious Adverse Event Follow Up Reporting Form (CTIMP) Pregnancy Reporting Form Pregnancy Follow Up Reporting Form Serious Adverse Events Tracker

16 SOP-RES-019: Adverse Event Reporting in Clinical Trials of Investigational Medicinal Version 1 Effective Date: 20 th May 2014 Page 16 of Appendices Appendix 1. Reporting of AE/ARs and SAEs for CI/PIs or Delegates From the time participant is consented: Adverse Event or Reaction observed? For NUH site studies: the CI/PI or delegate logs event on Datix Is the AE/AR serious? YES NO It is a Serious Adverse Event (SAE) or Reaction (SAR) All SAE/SARs must be recorded on TAFR01903_Serious Adverse Event Reporting Form (CTIMP). The SAE form must be sent to NUH R&I office within 24hrs of becoming aware of the event as per section 6.3 This is an AE. This does not require expedited reporting therefore report as per protocol on TAFR01901_Adverse Events Record Follow up if required. CI/PI COPIES PRINTED FROM THE WEBSITE ARE VALID ONLY ON THE DAY OF PRINTING

17 Appendix 2. Timeframes for Recording and Reporting of SAEs and SUSARs Serious Adverse Event (SAE) CI/PI (or delegate) completes SAE form. Report and send to NUH R&I office within 24hrs of becoming aware of the event. to: Telephone: Hand-deliver to NUH R&I, C Floor, South Block, QMC. The R&I representative records SAE details and the date/time of the telephone call in the Additional Comments The CI/PI (or delegate) records the date/time of the delivery in the Additional Comments R&I RPM must send confirmation of receipt within 1 working day to site. Site must provide omitted information in SAE form with 5 working days of initial receipt by NUH R&I. R&I RPM must send the SAE form to be independently assessed within 1 working day of initial receipt by NUH R&I. The Sponsors independent medical monitor assesses causality and expectedness within 24 business hours. Is the event expected? YES NO This is an SAE Requires SAE follow up reporting if additional information is subsequently provided This is a Suspected Unexpected Serious Adverse Event (SUSAR) Fatal or life-threatening? Refer to SOP-RES-023 for unbinding process and study protocol YES NO CI/PI Report to MHRA and the REC within 7 days Report to MHRA and the REC within 15 days Sponsor

18 Appendix 4. Pregnancy Reporting From the time participant is consented: Has a participant, or a female partner of a male participant, in a trial become pregnant? YES Pregnancy Reporting CI/PI (or delegate) completes using the Pregnancy Reporting Form (TAFR01905). Report and send to NUH R&I office within 14 days of becoming aware of the pregnancy. to: Telephone: Hand-deliver to NUH R&I, C Floor, South Block, QMC. The R&I representative records details and the date/time of the telephone call in the Additional Comments The CI/PI (or delegate) records the date/time of the delivery in the Additional Comments The R&I RPM will report to MAH (for trials using a licensed IMP) or to the MHRA (for trials using an unlicensed IMP) within 15 days Pregnancy Follow-up Reporting CI/PI (or delegate) completes using the Pregnancy Follow Up Reporting Form (TAFR01906). Report and send to NUH R&I office. CI/PI Sponsor

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