Sheffield Teaching Hospitals NHS Foundation Trust

Research Department

Principal Investigator Study Monitoring Self Declaration

Study title:
STH Number: / EUDRACT number:
PI at site: / Sponsor:
Study site address:
1 / Recruitment information
1.1 / Projected or actual first subject entry date
1.2 / Projected or actual study completion date e.g. Last Patient Last Visit (LPLV)
1.3 / Total number of participants planned for site
1.4 / Total number of participants screened
1.5 / Total number of participants in screening
1.6 / Total number of participants classed as screening failures
1.7 / Total number of participants currently on therapy
1.8 / Total number of participants who completed the study (not withdrawals)
1.9 / Total number of participants who are classed as withdrawn or lost to follow up

Please answer each question with Yes or No or a numerical answer where prompted.

If you answer No,please detail remedial action to be taken with a timescale, in the final column.

Topic / YES/NO / Remedial Action
2 / Study management
2.1 / There is a member of research team assigned to perform internal monitoring of study?
2.2 / There are written monitoring procedures in place?
2.3 / The research team have been adequately informed about the clinical protocol and investigational drug?
2.4 / There is evidence that the research team have current Good Clinical Practice (GCP) training?
3 / Investigator Site File
3.1 / There is an Investigator site file?
3.2 / The study has received a favourable opinion from a Research Ethics Committee?
3.3 / The current clinical protocol has been approved by a Research Ethics Committee?
3.4 / The Patient Information Sheet(s) and Informed consent Sheet currently in use have been approved by a Research Ethics Committee?
3.5 / The study has a MHRA Clinical Trial Authorisation?
3.6 / The current clinical protocol has been submitted to the MHRA?[*]
3.7 / There is a subject recruitment log?
3.8 / There is a subject screening log?
3.9 / There is an example Case Report Form (Data Collection Tool)?
4 / Pharmacovigilance
4.1 / The Investigational Medicinal Product is properly labelled, stored and the correct tracking documentation is in place?
4.2 / For each participant, the administration of the drug is noted in the CRF and patient notes and signed and dated by the person administering the drug?
4.3 / Participant drug compliance is reviewed and recorded at every visit?
4.4 / Concomitant medicines information is captured at every participant visit?
4.5 / There is a concomitant medicines CRF?
4.6 / Adverse events are collected at every participant visit?
4.7 / There is an adverse event log?
4.8 / Adverse events are documented, investigated and reported to the Sponsor, REC and MHRA as required?*
5 / Participant records and tracking
5.1 / The study is being conducted according to the approved protocol?
5.2 / The subject recruitment is being recorded and reviewed?
5.3 / Written informed consent has been obtained before any study procedures are performed?
5.4 / The subject status is being recorded?
5.5 / Source documents are being kept accurate, complete and maintained?
5.6 / There is a Case Report Form for each participant?
5.7 / Data on the CRF is consistent with source documents?
5.8 / Any missed visits, tests, dosing are documented on the Case Report forms?
5.9 / Case Report Form entry errors, omissions or illegibilities have been corrected, signed and explained?
6 / Reports
6.1 / Annual progress reports have been submitted to the REC?
6.2 / Annual safety reports have been submitted to the MHRA?*
6.3 / Any study status updates requested by the Research Department have been returned?
7 / If the study has completed
7.1 / End of Study declaration has been sent to the REC?
7.2 / End of Study declaration has been sent to the MHRA?*
7.3 / The final study report has been written?
7.4 / A summary of the final report on the research has been sent to the main REC? (within 12 months of the end of the project)?
7.5 / The study has been archived in accordance with the regulations?

I confirm that I understand that the information supplied may be submitted to a regulatory authorityas evidence of adequate study monitoringaccording to UK law.

I confirm that the information provided in this document is accurate and Itake full responsibility for it.

Signature______

Date

Name

Chief / Principal Investigator (delete as appropriate)

This action may be undertaken by the Sponsor. You should confirm this with your Research Department Coordinator where the study is sponsored by STH, or your Sponsor contact if the study is externally sponsored

Guidance to completing the Principal Investigator Study Monitoring Self Declaration

1 / Recruitment information
1.1 / Provide a date (dd-mm-yyyy)
1.2 / Provide a date( dd-mm-yyyy)
1.3 / Provide a numerical answer
1.4 / Provide a numerical answer
1.5 / Provide a numerical answer - participants in screening on date of review
1.6 / Provide a numerical answer
1.7 / Provide a numerical answer - participants currently active in study
1.8 / Provide a numerical answer- participants who completed all study visits
1.9 / Provide a numerical answer- participants who did not complete the study and have withdrawn from participation or are lost to follow up (i.e. have not attended study visits and can not be contacted to find out why)
Study Management
2.1 / The Principal Investigator (PI) at each site is responsible for the conduct of the study at that site. The Sponsor requires the PI to undertake adequate monitoring of study conduct as agreed under monitoring arrangements. The PI may delegate this responsibility of routine monitoring to an appropriately qualified and trained member of the research team. This must be documented in the site file delegation log.
2.2 / Written monitoring procedures may include investigator monitoring arrangements, monitoring checklist, SOPs etc
2.3 / Training should be documented in delegation log, study specific training log, team meeting minutes etc
2.4 / GCP training should be documented in the site file. If certificates are kept in personal training files, the location of these files should be documented in the site file.
3 / Investigator Site File
3.1 / Studies should have a site index based on ICH GCP section 08, the STH template is mandatory for STH sponsored studies.
3.2 / The Investigator site file should have a copy of the favourable opinion letter from the main Research Ethics Committee. The letter should cite which documents are approved for use. For multi-centre studies an appendix showing that the site has Site Specific Assessment should also be filed.
3.3 / The protocol in use should be the same version as cited in the REC approval letter. Any amendments to study documents including protocol, Patient Information Sheet, Informed Consent Form, Patient/GP letters and adverts should be approved by the REC before use. A favourable opinion letter citing the version and date of the amended document from the REC should be filed in the Investigator Site File.
3.4 / The Informed Consent Form and Patient information Sheet in use should be the same version as cited in the REC approval letter.
3.5 / For studies involving an Investigational Medicinal product (IMP) as defined by the Medicines for Human Use (Clinical Trials) Regulations 2006 a Clinical Trial Authorisation (CTA) “notice of acceptance “ letter from the Medicines and Healthcare Products Regulatory agency (MHRA) should be filed.
3.6 / The CTA applies only to the protocol that was submitted with the original application. Any amendments to the protocol should be submitted to the Sponsor so an amendment can be submitted to the MHRA where appropriate. An amended protocol should not be implemented until the Sponsor has confirmed that the appropriate regulatory approvals are in place.
3.7 / A log should be maintained to identify which patients have been recruited into the study. A template can be found on the STH Research Department website under R&D authorisation/site file templates.
3.8 / A log should be maintained to identify which patients have been screened into the study. It is advised to record the reasons for screen failures for use in any future review of recruitment strategy. A template can be found on the STH Research Department website under R&D authorisation/site file templates.
3.9 / A copy of the template Case Report Form (CRF) being used for data collection should be kept in the Investigator Site File.
4 / Pharmacovigilance
4.1 / If the PI has delegated this responsibility to pharmacy this should be clearly documented in the Investigator site file. The PI should have a record on participant drug compliance, documenting review at each study visit.
4.2 / Administration of the drug should be noted in both the CRF and the patient notes. The dates should match up and the person responsible for administering the drug (as detailed in the delegation log) must sign and date both documents.
4.3 / Participant compliance should be recorded at each visit in order to achieve valid study data as well as allowing appropriate identification of causality of any SAEs that occur.
4.4 / Con med information must be captured at each visit in order to identify participants that may need to be withdrawn from the study and to allow appropriate identification of causality of any SAEs that occur.
4.5 / A template con med CRF isavailable on request from the Research Department.
4.6 / An attempt to elicit adverse events from particpants should be made at each study visit and this attempt and any answers should be documented.
4.7 / A template adverse event CRF page is available from the STH Research Department.
4.8 / There should be documentation to show that any SAEs were reported to the Sponsor within 24 hours and any SUSARS investigated and reported to the REC and MHRA as required.
5 / Participant records and tracking
5.1 / All visit, procedure and tests stated in the protocol should be completed for all patients. Inclusion and exclusion criteria for each recruited patient should be checked and confirmed as correct. It may be useful to include a page in the CRF for this purpose (Generic page to be drafted by STH RD) There should be documentation to show that any deviations to the protocol have been reported to REC and Sponsor.
5.2 / Review the recruitment log to ensure that patient details and status are up to date. Review the recruitment rate against original predications and consider review of the recruitment strategy.
5.3 / The Investigator Site File should have a copy of the Informed Consent Form (ICF) for each participant. The version number on the ICF used should correspond to that approved by the REC. The ICF should signed by both the PI and the participant on the same day. The date of the signature should be prior to any study procedures. If anyone other than the PI has taken consent the delegation of this responsibility should be documented on the delegation log. A copy of the ICF should be filed in patient’s notes and study participation and ICF should be noted.
5.4 / As part of the oversight of the study the PI should ensure that there is system to track of the status of particpants for example visits completed and scheduled, date participant completed, withdrew or was lost to follow up (template to be drafted by STH RD)
5.5 / Source documents may include patient notes, lab results, ECG traces etc
5.6 / Each participant should have a separate CRF. The CRF should not contain any patient identifiable details
5.7 / Cross reference with the data on the Case Report Form with source documents to ensure they are consistent
5.8 / If any data fields on the CRF are not completed due to missed visits, tests, dosing or participant withdrawal ensure there are signed and dated comments to explain why.
5.9 / Please see STH guidance on good practice in relation to CRF completion – available on Research Department website under R&D authorisation/project guidance.
6 / Reports
6.1 / A progress report should be submitted to the REC which gave a favourable opinion of the research 12 months after the date on which the favourable opinion was given. Copies of the report should be filed in the Investigator Site File and submitted to your Research Coordinator in the STH Research Department.
6.2 / A safety report will be submitted to the MHRA on an annual basis by the Sponsor or delegate whether or not a SUSAR has occurred. A copy of the report should be filed in the Investigator Site File
6.3 / STH Research Department routinely ask for updates on the status if projects so that records can be kept accurate and up to date. A copy of the response sent should be filed in the Investigator Site File.
7 / If the study has been completed
7.1 / The Chief Investigator is responsible for sending an End of Study declaration to the REC. The declaration should be sent to the REC within 90 days of the end of the trial or 15 days if the trial is ended prematurely. Forms can be found on the COREC website. The definition of the end of the project should be provided in the protocol and any change to this definition should be notified as a substantial amendment. In most cases, it will be the date of the last visit of the last participant or the completion of any follow-up monitoring and data collection described in the protocol. A copy of the letter sent to the REC and the REC acknowledgment should be filed in the Investigator Site file and a copy of the documentation should be sent to the Research Department.
7.2 / A notification of the end of study should be sent to the MHRA by the Sponsor or delegate within 90 days of its conclusion. A copy of the letter and the MHRA acknowledgment should be filed in the Investigator Site File.
7.3 / Please provide the Research Department with a copy of the final report.
7.4 / A summary of the final report on the research should be sent to the main REC within 12 months of the end of the project. There is no standard format for final reports. As a minimum, the main REC should receive information on whether the project achieved its objectives, the main findings and arrangements for publication or dissemination of the research, including any feedback to participants. A copy of the letter sent to the REC and the REC acknowledgment should be filed in the Investigator Site file and a copy of the documentation should be sent to the Research Department.
7.5 / Details on where the study documentation has been archived should be retained by the PI. The PI or delegated archivist should retain documentation to details what documentation is stored where Materials need to be readily accessible in the event of audit or regulatory inspection.

V1 30Jan07

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[*]This action may be undertaken by the Sponsor. You should confirm this with your Research Department Coordinator where the study is sponsored by STH, or your Sponsor contact if the study is externally sponsored