information (content and wording) to support their ability to give fully informed consent - Advertisement for subject To document that recruitment X X X measures are appropriate and recruitment (if used) not coercive Financial aspects of the trial To document the financial X X (auto) agreement between the (including funding investigator/institution and the application/award letter) sponsor for the trial Insurance statement To document that X X X (auto) compensation to subject(s) for (where required; for CTIMPs trial-related injury will be insurance/indemnity cover is a available legal requirement) Signed Agreement between involved parties, e.g.: Investigator/Institution To document agreements X X X and Sponsor (Clinical Trial Site Agreements) Investigator/Institution To document agreements X X X and parties, eg. (where Vendors, coordinating required) centre etc Charter signed by Data To document expectations of X both parties, e.g. via a charter Monitoring Committee members Sponsor and Chief To document expectations of X X both parties, e.g. via CI Investigator Declaration Form or CI Agreement
information (content and wording) to support their ability to give fully informed consent - Advertisement for subject recruitment (if used) To document that recruitment measures are appropriate and not coercive X X X Financial aspects of the trial (including funding application/award letter) To document the financial agreement between the investigator/institution and the sponsor for the trial X X (auto) Insurance statement (where required; for CTIMPs insurance/indemnity cover is a legal requirement) To document that compensation to subject(s) for trial-related injury will be available X X X (auto) Signed Agreement between involved parties, e.g.: Investigator/Institution and Sponsor (Clinical Trial Site Agreements) To document agreements X X X Investigator/Institution and parties, eg. Vendors, coordinating centre etc To document agreements X X (where required) X 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
UoB-CLN-ESD-QCD-001%20Essential%20Document%20Checklist%20CTIMPs%20v.%201.0%20(EAv1.0).docx