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 been subject to REC review Opinion of Research Ethics and given favourable opinion. Committee (REC) of the following To identify the version number including any revisions: and date of the document(s). Protocol and any To document that the amendments favourable opinion is Informed Consent maintained throughout the Form(s) trial. Documents include the Any other 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 NHS permissions (if applicable) To document NHS permission X X X was gained for an individual including application, approval NHS site to participate in the letter and correspondence trial Regulatory Authority(ies) To document appropriate X X X authorisation by the regulatory Clinical Trial Authorisation, authority(ies) has been including maintaining obtained prior to initiation of
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 other 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 NHS permissions (if applicable) including application, approval letter and correspondence To document NHS permission was gained for an individual NHS site to participate in the trial X X X Regulatory Authority(ies) Clinical Trial Authorisation, including maintaining To document appropriate authorisation by the regulatory authority(ies) has been obtained prior to initiation of X X X
UoB-CLN-QCD-002-Essential-Document-Checklist-CTIMPs-v--1-0-dd---15-Aug-2---.docx