protocol approval

protocol approval (sponsor)

A clinical trial term of art for a sponsor action that follows completion of protocol development, which is marked when the signature of the last reviewer on the protocol approval form has been obtained, signifying that all reviewer changes to the protocol have been incorporated.

Approval by the sponsor usually initiates secondary approvals by institutional review boards (IRBs), regulatory authorities and sites. Protocol amendments usually also require a cycle of approval by sponsor and study staff before taking effect.
References in periodicals archive ?
The Regulatory Committee is a component of the Institutional Review Board and integral to the protocol approval process to commence the study, commented Dr.
Also, CrystalGenomics has recently obtained a phase 2 study protocol approval from the MFDS for its molecular targeted anti-cancer therapeutic.
The FDA expansion protocol approval permits the company to implant an additional 20 patients and to add two new study sites.
Following protocol approval by the FDA, Lux says it expects to initiate pivotal trials in early 2007, with an estimated New Drug Application (NDA) submission scheduled for early 2009.
The Council's adoption of the Decision closes the Accession Protocol approval procedure, the first stage of which consisted in the signing of the agreement on the Community's behalf in October 2002.
a) perform a technical review of all devices defined below, together with the decision of the technical and protocol approval for medical use for a period of one year,
protocol approvals, closures, and confirmations for non-human subjects research; 3) filing approval memos; and 4) managing the IRB process' common e-mail inbox.