Conduct clinical trial monitoring activities for the WHO ACTION-I Trial (Kenya)

WHO is seeking offers for clinical trial monitoring services. Your Company / Institution is invited to submit a proposal for the services in response to this Request for Proposals (RFP).

The purpose of this contract is to conduct clinical trial monitoring activities for the ACTION-I Trial at four participating hospitals in Kenya (Nairobi area and Mombasa).

The purpose of trial monitoring activities is to verify that:

• The rights and well-being of human participants are protected.
• The captured trial data are accurate, complete, and verifiable from source documents.
• The conduct of the trial is in compliance with the approved protocol/amendment(s), with GCP, and with the other relevant local and international standards

Activities include the conduct of in-person site visits to study sites. These visits will include assessment of study documentation, assessing use of study drugs, source data verification, query generation and resolution (as required). The successful bidder will receive the WHO ACTION Trials monitoring manual and standard reporting templates to guide monitoring and reporting activities.

See detailed Terms of Reference and information attached.

RFP-ACTION trials monitoring_KEN_9FEB19.pdf
RFP_TOR_KEN_9FEB2019.pdf