CMCR AND REGULATORY PROCESS GUIDELINES:
SUMMER CALL 2006

CLINICAL TRIALS PROPOSALS

Investigators are responsible for the items listed in BOLD BLACK.
The CMCR staff will coordinate items listed in Blue.

  1. Review the Program Announcement and Call for Proposals. Application packets are also available from CMCR by calling 619-543-5024 or by e-mail request to bgouaux@ucsd.edu.
  2. Investigators are encouraged to submit a letter of intent and/or a brief 1-2 page Concept Statement to CMCR by May 1, 2006.
  3. Review the instructions and submit a completed application reviewed by your contracts and grants office to the CMCR by June 1, 2006, 4:00 pm. Please note that your grant must have been reviewed by your contracts and grants office before submission to the CMCR.
  4. Submit completed IRB application to your Institutional Review Board by June 1, 2006.
  5. Proposals will be reviewed by CMCR and forwarded to the Scientific Review Board June 8, 2006.
  6. Investigator notification of outcome of scientific review is anticipated by August 4, 2006.
  7. Proposals will be forwarded by CMCR to Health and Human Services (HHS) for review by an anticipated date of August 18, 2006.
  8. Proposals will be forwarded to the Research Advisory Panel of California by August 18, 2006 for the September 2006 Panel meeting.
  9. Investigator will apply (with CMCR assistance) to DEA for Schedule I registration by the anticipated date of August 18, 2006.
  10. Proposals and IND applications will be forwarded by CMCR to the appropriate division of FDA's Center for Drug Evaluation and Research by an anticipated date of October 27, 2006. There will be a minimum of 30 days for approval from FDA.
  11. Anticipated date of application to NIDA for shipment of product is January 12, 2007.
  12. Studies may begin upon arrival of the investigational drug products, approximately January 26, 2007.

CMCR Staff members are available to answer questions and assist investigators in expediting the application and regulatory process. Call 619-543-5024 or e-mail bgouaux@ucsd.edu for assistance.