Staff signature lists (provide an updated reference of research staff, past and present; useful for long studies, studies with a large number of staff, and/or high staff turnover). members’ printed names, original signatures and signed initials, titles or roles (e.g. research nurse, study coordinator, PI). Confirmation of regulatory approval (e.g. SAHPRA approval) In FDA-regulated studies: signed FDA 1572 and clinical investigator financial disclosure for each listed investigator. In NIH-sponsored studies: copy of NIH grant and progress reports. Signed and dated investigators’ CVs. Investigator’s brochure. If an investigational drug or device study: device manual, package insert, dose administration guide. Laboratory Certification: Laboratory director’s CV Laboratory normal reference values, including updates Study Tracking Logs/Worksheets: Human Research Ethics Committee tracking log Screening log (which documents and tracks all potential participants that were considered and screened for the study) Was informed consent obtained prior to screening? How and where was participant recruited? Reasons for exclusions/ineligibility Was the Committee notified of study exceptions? Participant recruitment log: Total contacted, total response, total enrolled. Reasons for early withdrawals or exclusions. How many participants is the site approved to enrol? Are all recruitment methods and materials approved by the HREC? Monitoring log (offers a record of all monitoring visits and any corresponding letters, reports and changes resulting from the visit; also offers documentation of all outside persons who have had access to confidential study materials and when). Have all monitoring reports, such as a DSMB reports, been submitted to the Human Research Ethics Committee? Study Standard Operating Procedures. Approved Protocol: current version and previous versions. Informed Consent Form: current version and previous versions: Is there a consent form for each participant? Who signed the consent form (participant, parent, legally authorised representative)?
Staff signature lists (provide an updated reference of research staff, past and present; useful for long studies, studies with a large number of staff, and/or high staff turnover). members’ printed names, original signatures and signed initials, titles or roles (e.g. research nurse, study coordinator, PI). Confirmation of regulatory approval (e.g. SAHPRA approval) In FDA-regulated studies: signed FDA 1572 and clinical investigator financial disclosure for each listed investigator. In NIH-sponsored studies: copy of NIH grant and progress reports. Signed and dated investigators’ CVs. Investigator’s brochure. If an investigational drug or device study: device manual, package insert, dose administration guide. Laboratory Certification: Laboratory director’s CV Laboratory normal reference values, including updates Study Tracking Logs/Worksheets: Human Research Ethics Committee tracking log Screening log (which documents and tracks all potential participants that were considered and screened for the study) Was informed consent obtained prior to screening? How and where was participant recruited? Reasons for exclusions/ineligibility Was the Committee notified of study exceptions? Participant recruitment log: Total contacted, total response, total enrolled. Reasons for early withdrawals or exclusions. How many participants is the site approved to enrol? Are all recruitment methods and materials approved by the HREC? Monitoring log (offers a record of all monitoring visits and any corresponding letters, reports and changes resulting from the visit; also offers documentation of all outside persons who have had access to confidential study materials and when). Have all monitoring reports, such as a DSMB reports, been submitted to the Human Research Ethics Committee? Study Standard Operating Procedures. Approved Protocol: current version and previous versions. Informed Consent Form: current version and previous versions: Is there a consent form for each participant? Who signed the consent form (participant, parent, legally authorised representative)?