Please use the updated 2017 instructions for completing the CRC form, and the 2017 fillable CRC approval form available here.
- PI fills out and submits a CRC form to Alison Moeller at email@example.com
- CRC form will be submitted to the CRC committee for their review; the review process will take approximately 2 weeks.
- The committee’s comments are compiled into a document and will be sent to the PI via email. PI will need to respond to the committee’s questions and make necessary changes to the protocol, budget or the consent form, and email it to Alison Moeller at firstname.lastname@example.org. This process can be repeated a few times depending on questions, and this process can take another two weeks.
- Once your CRC has been approved, you will receive an approval letter via email from Dr. Cheryl London.
After approval of the CRC and IACUC forms, the BBVCTO generates a contract that defines study related tasks to be performed by the office staff, and outlines responsibilities of the PI with respect to study specific duties.
The PI responsibilities may include the following elements:
- Provide BBVCTO with a copy of the approved proposal, containing an accurate budget that includes all relevant direct and indirect costs.
- Generate a study plan in the form of a protocol including consent form, case report forms (CRCs) and detailed study procedures.
- Address all potential adverse events, and provide appropriate budgetary support should these occur.
- Ensure that patients entered into clinical trials meet inclusion criteria.
- Obtain a signed client consent form, and maintain client contact as needed.
- Oversee all patient care during conduct of the clinical trial.
- Each PI must provide additional study contacts should he/she not be available to address the needs of a study patient. It is strongly recommended that any clinical trial have at least one if not two co-investigators to insure that patient needs can be adequately addressed in a timely manner.
- Perform data entry and sample collections as specified in the study guidelines.
- Implement final analysis upon study completion.