Steps to begin a Clinical Research Study at UW

Please note: The sequence of the steps may vary depending upon funding source.

• Step 1:  Confidential Disclosure Agreement Requirements

• Step 2a:  Regulatory Requirements for Studies Utilizing the Office of Clinical Trials
  OR
  Step 2b: Regulatory Requirements for Studies Not Utilizing the Office of Clinical Trials

• Step 3:  Research Budgeting and Billing

Step 1: Confidential Disclosure Agreement Requirements

Most industry sponsors require a Confidential Disclosure Agreement (also called Confidentiality Agreement, or CDA; Secrecy Agreement, Non-disclosure Agreement) to be signed before they will send a full protocol. The university must sign the CDA; sponsors often want the principal investigator to sign but the UW considers CDAs to be agreements with the institution, not the investigator. To process Confidential Disclosure Agreements:

1. Route document with Transmittal Form (“T-form”) to Research and Sponsored Programs (RSP) through the department and dean's offices with the Principal Investigator and Chair signatures.

2. a. Indicate on the T-Form that this is the Initial Review of the agreement. The Sponsor section (#5) or Proposals (#9) after New can be used to indicate initial review.

b. Indicate on the T-Form the type of agreement (CDA).  The Project Title or #9 Awards Other can be used for this.

c. No budget or clearance information is needed at this time.

3. The Dean's office will review agreements before routing to RSP.

4. RSP will log the agreement into the Pre-Award Login System (PALS) where it will be assigned a routing number. You can check the status of the agreement at PALS.

5. RSP reviews the agreement for University policy and state law issues. 
   RSP negotiates with the sponsor until the agreement is in accordance with those policies and laws.

6. When the agreement is in final form, RSP sends it, with a cover letter, to the Contact Person named on the T-Form.  The cover letter will have the PALS Routing Number plus signature lines for the Principal Investigator, the Chair and the Dean.

RSP will sign the CDA and send it to the sponsor. Be sure to include sponsor contact information when routing the CDA as described above. If the sponsor wants the original, please include a pre-paid air bill with sponsor account information.

For investigators using the Office of Clinical Trials services (IRB application preparation, etc), the CDA can be processed in its entirety by OCT.

Step 1 | Step 2 | Step 3