Sponsors must collect and fully execute Confidentiality Disclosure Agreements (CDAs) with all sites and investigators intended for inclusion in the clinical trial.
As with any other aspect of a clinical trial, efficiency in this step can have a significant impact on the timelines and milestones set for the study. The process for executing CDAs varies based on sponsor and CRO standard operating procedures (SOPs).
By their very nature, CDAs put the trial at risk for unnecessary delays because they are inconsistent. One reason for a delay could be that the site wants to negotiate terms of the CDA, which involves the legal department of the sponsor and/or CRO, and several days, if not weeks, can go by before an agreement is reached.
Other possible delays could be due to multiple parties requiring multiple CDAs (Sub-Investigator's (Sub-I's), site, and Primary Investigator (PI).)
Add to that the cumbersome process of managing the dissemination, completion and collection of CDAs for all sites and investigators, and this simple yet crucial document can be accountable for noteworthy study startup delays.
How CDAs are sent and tracked
Typically, the sponsor sends the CDA to each site through email, fax, or mail. After circulating the document back and forth with the sites and obtaining the appropriate signatures, moving to the next step often involves the sponsor "batching" the signed CDAs. This means that the partially executed CDAs will be taken for full execution at a set time, such as every Friday. This next step—sending the protocol—follows in a similar batch fashion. Alternatively, CDAs may be handled in a piece-meal fashion, where each site moves on to the next step as soon as their returned CDA is received.
This all has to be done on a set timeline, otherwise investigator recruitment can begin falling behind schedule, thus delaying site activation, first patient enrolled, and database lock. In many companies, this is an extremely manual and labor-intensive process, requiring too much follow up tracking via spreadsheets on the part of the sponsor to assure timeliness and accuracy.
A system should be in place for the sponsor to:
- Create and disseminate CDAs in bulk to sites and investigators
- Track receipt of signed CDAs
- Generate internal and external alerts when timelines are not met
- Internally manage site requests for custom CDAs with efficiency
- Incorporate in the SOPs the acceptance of an electronic version to move on to the next step in the process
Research Project Lead
Sunshine Coast Hospital and Health Service
"The success of any site selection and initiation can be improved by activating a blanket approval for initial relationships to be initiated and maintained. Good sites are a reflection of the relationships with sponsors and their representatives. Strategic site relationships build trust, and with an efficiently organized site this can contribute to realistic trial recruitment and budget expectations. The increasing use of technology is very welcome to simplify communications and streamline processes"
Sites should have processes in place for the management of CDAs, including the receipt, review, execution, return, and internal filing of the CDA. Communication by the site should also be transparent. For example, if the PI is required to sign and is currently on a vacation, will it be acceptable to wait, or will it be required to track the PI down and obtain a signature ASAP?
This is an expected and standard process within all clinical trials. Open and clear communication by all parties as well as sound, professional processes in place will ensure the efficient completion of this step, usually within 48 hours.
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