Topical Treatment of Cutaneous Leishmaniasis with WR279396: A Phase II Study in the Old World
Abstract
Action was taken in three directions: 1) Coordination between sites. The French Study Coordinator visited the Tunisian site (April). The Tunisian Study Coordinator visited the French site (July). Team members involved were identified. The protocol and SOPs were improved. A contract was raised between the Institut Pasteur in Paris and the Institut Pasteur in Tunis to define money transfers and responsibilities. 2) Regulatory issues Approval from the Local Tunisian Ethical Committee was obtained. Approval from Tunisia Ministry of Health is ongoing. In France, the second submission to the French IRB will be sent on July 16th 2002. A first-step approval from the French commission for computerized data handling was obtained (2d of July). The second step should be completed before August 8th 2002. The project was submitted to the AFSSAPS (French equivalent of the F.D.A). Final approval depends on the French IRB approval (end of August). A contracted company (CREAPHARM) will impact the study product from the United States to France. A Federal Wide Assurance for Subjects Protection was signed (7th of July).
Document Details
- Document Type
- Technical Report
- Publication Date
- Jul 01, 2002
- Accession Number
- ADA410397
Entities
People
- Pierre A. Buffet