Clinical trial sites may have internal personnel challenges due to the attrition, unanticipated complexity, duration, and/or difficulty in carrying requirements to conduct clinical trials.
Supplier-based Site Resource Support Services may be available to support clinical trial sites by providing temporary study coordinator or clinical research coordinator support for specific activities for a Merck & Co. trial.
Two categories of Supplier-based Site Resource Support Services are available for use following Clinical Trial Research Agreement (CTRA) execution.
1. Site Resource Augmentation
a. Intended to be short term support for up to 12 months
i. Extension may be considered only if per-patient-cost remains within FMV
b. Number of hours and duration of support must be within fair market value of per-patient cost within a clinical trial site’s study grant
2. Site Resource Placement
a. Intended to be long term support for longer than 12 months
b. Clinical trial site’s study grant must remove/ reduce line items for Study Coordinator / Data Entry costs for the duration of Site Resource Placement
These activities may include:
- Chart Review/ Pre-screening
- Data Entry / Query Resolution
- Patient Referral Management
- Regulatory Documentation Admin Support
- Other activities may be in-scope as agreed to by MSD on an as-needed basis
All resources placed at clinical trial site must be under Principal Investigator (PI) oversight and listed on the study Delegation of Authority/ Site Role & Responsibilities Log. In addition, a clinical trial site must execute a Business Associates Agreement with an approved supplier.
Suppliers available for global use include the below. Additional local supplier may be available in some countries.
