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.
Segen's Medical Dictionary. © 2012 Farlex, Inc. All rights reserved.
References in periodicals archive ?
After our group had fulfilled all requisites for protocol approval, PTCA balloons, which were solely manufactured by the USCI Company in the United States, were still not available because manufacturing could not keep up with the demand.
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.
The ethical committees must promote and request this registry at the time of protocol approval; the regulatory entities must demand it in the case of solicitation for approval of a new drug or medical equipment; and the editors at the time of article submission to scientific journals.
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.
The implications of not doing so can delay protocol approval, leading to lengthy completion times.
The tasks identified included 1) using checklists to ensure required documents and training have been submitted/completed for each research protocol; 2) sending letters, i.e., protocol approvals, closures, and confirmations for non-human subjects research; 3) filing approval memos; and 4) managing the IRB process' common e-mail inbox.