Charter signed by Data To document expectations of X Monitoring Committee both parties, e.g. via a charter members Sponsor and Chief To document expectations of X X Investigator both parties, e.g. via CI Declaration Form or CI Agreement Letter of Sponsorship To document that the Sponsor X X X(auto) has agreed to take on Sponsorship responsibilities for the trial Dated, documented Favourable To document that the trial has X X X Opinion of Research Ethics been subject to REC review and Committee (REC) of the following given favourable opinion. To including any revisions: identify the version number and date of the document(s). Protocol and any amendments To document that the favourable Informed Consent opinion is maintained throughout Form(s) the trial. Documents include the Any written application form and information to be correspondence. provided to the subject(s) Advertisement for subject recruitment (if used) Subject compensation (if any) Any other documents given Approval/ Favourable Opinion Along with REC composition for each Favourable Ethical Opinion
Charter signed by Data Monitoring Committee members To document expectations of both parties, e.g. via a charter X Sponsor and Chief Investigator To document expectations of both parties, e.g. via CI Declaration Form or CI Agreement X X Letter of Sponsorship To document that the Sponsor has agreed to take on Sponsorship responsibilities for the trial X X X(auto) Dated, documented Favourable Opinion of Research Ethics Committee (REC) of the following including any revisions: Protocol and any amendments Informed Consent Form(s) Any written information to be provided to the subject(s) Advertisement for subject recruitment (if used) Subject compensation (if any) Any other documents given Approval/ Favourable Opinion Along with REC composition for each Favourable Ethical Opinion To document that the trial has been subject to REC review and given favourable opinion. To identify the version number and date of the document(s). To document that the favourable opinion is maintained throughout the trial. Documents include the application form and correspondence. X X X
UoB-CLN-ESD-QCD-001-Essential-Document-Checklist-CTIMPs-v.-2.0-dd01-Mar-2016.docx