Inactive
8(a) Set-Aside (FAR 19.8)
Notice ID:75N91020R00042
THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL BE ISSUED ON A LATER DATE. Title: Support of Cancer Therapeutics Evaluation Program’s Protocol Information Office (PIO) BACK...
THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL BE ISSUED ON A LATER DATE. Title: Support of Cancer Therapeutics Evaluation Program’s Protocol Information Office (PIO) BACKGROUND: The Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI), plans, assesses and coordinates all aspects of cancer treatment clinical trials. CTEP develops new pharmacological and biological agents for the treatment of cancers. CTEP’s responsibilities for developing, designing, conducting and managing ethical clinical trials requires the collection, assimilation, storage, analysis and communication of this clinical data within and outside of CTEP. The purpose of this contract is to support the PIO by coordinating all administrative aspects related to clinical trial document review, in order to ensure that quality protocols are developed in the most expeditious and efficient manner possible. To that end, the contractor shall: Utilizing various database and document tracking/reviewing applications to electronically track a protocol throughout its lifecycle. • The Contractor shall abstract information from protocol-related documents such as Project Team Member Applications (PTMAs), Letters of Intent (LOIs), Concepts, new protocols, protocol revisions or amendments. These documents are received for all CTEP-sponsored trials as well as a subset of trials sponsored by other Institutes, Divisions or Programs. The Contractor shall utilize established Standard Operating Procedures (SOPs) and User Guides as tools to determine what information needs to be abstracted depending on the type of document received. The Contractor shall review all submitted documents for completeness and accuracy, communicate electronically regarding “incomplete submissions”, and enter milestones on each protocol related record created when the milestone occurs. The Contractor shall create a process for performing quality control (QC) checks on abstracted information Supporting of Protocol-Related Material • The Contractor shall prepare an electronic protocol file for storage within NCI’s computer servers and select the appropriate reviewers. The Contractor shall distribute the review packets via a government provided electronic review system and expect to receive the reviews generated by reviewers electronically. The Contractor shall issue an electronic reminder to the reviewer(s) as needed. • The Contractor shall issue electronic consensus review letters, follow-up review letters, decision letters, and coding letters to the submitter usingestablished SOPs. The Contractor shall comply with current CTEP business rules that govern processes related to the regulatory requirements. The Contractor shall, with the approval of the COR, issue special mailings and notices regarding various safety, regulatory or other related information to sites conducting CTEP-sponsored trials. Supporting Meetings • The Contractor shall prepare the meeting packets for the Investigational Drug Branch (IDB), Concept Review Meeting (CRM), Biomarker Review Committee (BRC), Protocol Review Committee (PRC) meetings and other CTEP study related meetings. • The Contractor shall generate the preliminary and final meeting agendasand shall distribute these agendas based on a designated schedule. • The Contractor shall send a representative to each meeting to address or record PIO-related issues for resolution, such as requests for additional documentation to the study team. The Contractor shall circulate OEWG conference call attendance forms to the Lead Reviewer for approved LOIs, Protocols and Concepts after the meeting. Assisting CTEP with the tracking of Operational Efficiency Working Group (OEWG) timelines • The Contractor shall schedule conference calls for approved or on hold LOIs, concepts and protocols. The Contractor shall also schedule ad hoc calls between CTEP staff and study team members. The Contractor shall attend the conference calls and prepare meeting minutes from the calls. The Contractor shall collaborate with other NCI staff and contractors involved in the protocol review process (i.e. CTSU, CIRB, CTMS) to minimize redundancy and gaps in supporting the protocol review process. • The Contractor shall maintain up to date electronic reports documenting current status of each protocol. Storing electronic materials and document Standard Operating Procedures (SOP). • The Contractor shall utilize the main PIO email address for all PIO-related correspondence. The Contractor shall use the established NCI network drives to store all protocol-related documents.
