- Advertisement for subject To document that recruitment X X X measures are appropriate and recruitment (if used) not coercive Financial aspects of the study To document the financial X X (auto) agreement between the (including funding investigator/institution and the application/award letter) sponsor for the study Insurance statement To document that X X X (auto) compensation to subject(s) for (where required) study-related injury will be available Signed Agreement between involved parties, e.g.: Investigator/Institution To document agreements X X X Where applicable, directed by Sponsor and Sponsor (Clinical Study Site Agreements) Investigator/Institution To document agreements X X X Where applicable and third 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 Letter of Sponsorship To document that the Sponsor X X X(auto) has agreed to take on Sponsorship responsibilities for the study
- Advertisement for subject recruitment (if used) To document that recruitment measures are appropriate and not coercive X X X Financial aspects of the study (including funding application/award letter) To document the financial agreement between the investigator/institution and the sponsor for the study X X (auto) Insurance statement (where required) To document that compensation to subject(s) for study-related injury will be available X X X (auto) Signed Agreement between involved parties, e.g.: Investigator/Institution and Sponsor (Clinical Study Site Agreements) To document agreements X X X Where applicable, directed by Sponsor Investigator/Institution and third parties, eg. Vendors, coordinating centre etc To document agreements X X (where required) X Where applicable 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 study X X X(auto)
Essential-Document-Checklist-non-CTIMPs-v--1.docx