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 ?
Bottlenecks in the Agencia Nacional de Vigilancia Sanitaria (ANVISA) submission and approval processes have meant that protocol approval takes 12 to 15 months in Brazil and an average of 6 months in Argentina.
Also, CrystalGenomics has recently obtained a phase 2 study protocol approval from the MFDS for its molecular targeted anti-cancer therapeutic.
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.
Key restraints for growth in Argentina and Brazil are related to regulatory issues such as long protocol approval timelines.
Seven of the participating centers demonstrated best practices in implementing a value stream analysis of the protocol approval process.
AcelRx plans to initiate a Phase 2 study, pending protocol approval, for a fourth product candidate, ARX-04, a sufentanil formulation for the treatment of moderate-to-severe acute pain, funded through a grant from USAMRMC.
On a much more positive note, during that same phone conversation with the USDA, they acknowledged that notwithstanding the protocol approval error the animal testing results which had been completed indicated that the vaccine was, as we expected it would be, "efficacious".
Protocol approval for the Phase III clinical studies on Prehistin is now in process.
Subject to protocol approval by the FDA the Phase II programs in both asthma and allergic rhinitis are on schedule to commence in the first half of this year.
As evidenced by this week's announcement that it had received protocol approval to conduct its first human clinical trial for CDT(TM), the Company is accelerating its entry into the $20 billion U.
This is due to Netherlands' favorable regulatory environment, streamlined protocol approval process and lower cost of managing trials.