10 Steps to Clinical Study Startup: Step 3 – Sending CDAs to Sites

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10 Steps to Clinical Study Startup: Step 3 – Sending CDAs to Sites

Jae Chung

This is the third installment of our ongoing series on 10 steps to Clinical Study Start Up. We hope you enjoy it. And of course feedback/comments/thoughts are welcome!

Introduction

Sponsors and CROs must collect and fully execute Confidentiality Disclosure Agreements (CDAs) with all sites and investigators intended for inclusion in their particular clinical trial. As is the case with any other aspect of a clinical trial, the efficiency by which this step is accomplished can have a significant impact on the timelines and milestones set for the study.

The process varies dependent upon sponsor and CRO standard operating procedures (SOPs). By virtue of the inconsistencies around CDAs, the trial is already at risk for unnecessary delays. Add to that the cumbersome nature of managing the dissemination, completion, and collection of CDAs for all sites/Investigators, this simple and crucial document can be held accountable for noteworthy study startup delays.

There are a wide variety of reasons that could lead to delays in this step. 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 &/or CRO, and several days, if not weeks, can go by before an agreement is reached. Other possible delays could be due to shipping mishaps or multiple parties requiring multiple CDAs (Sub-I’s, site, and PI).

How CDAs are currently sent and tracked

Currently, the Sponsor/CRO needs to send 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 may involve the sponsor/CRO “batching” the signed CDAs. This means that the partially executed CDAs will be taken for full execution at a set time (e.g. every Friday). This is followed by the next step (e.g. sending the protocol) in a similar ‘batch’ fashion. Alternatively, the 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 time-line, otherwise investigator recruitment can begin falling behind schedule, thus delaying site initiations, first patient enrolled, and database lock. In many companies, this is an extremely manual and labor intensive process, requiring much followup on the part of the sponsor/CRO to assure timeliness and accuracy.

Some key tips for the sponsor/CRO as well as the site are:

To ensure efficiency with CDA process, the sponsor/CRO should communicate their needs early and clearly with the sites.

1. Does the CDA need to be executed prior to the receipt of the study questionnaire synopsis?
2. Does the execution of the CDA only preceed the sharing of the protocol, following the first wave of feasibility questionnaires?
3. How will the site/PI specific information be incorporated into the CDA?
4. Who is/are the party(ies) with whom CDAs will be required? (Some require the site to sign, others the PI, and still others will require both, including any sub-Is.)
5. Will the sponsor or CRO send an editable version in Word, or do they want just the pertinent information from the site, so that they may customize the document?
6. Will the sponsor/CRO accept a scanned version of the signed CDA to expedite the process of moving on to the next step?

A system should be in place for the sponsor/CRO to:

1. Create and disseminate CDAs en masse to sites and investigators
2. Track receipt of signed CDAs
3. Generate internal and external alerts when time lines are not met
4. Internally manage site requests for custom CDA’s with efficiency
5. Incorporate in the SOPs the acceptance of an electronic version to move on to the next step in the process, reducing the impact of this process by several days to a week.

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 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?

The timeline in this process for a site should not exceed 48 hours.

Conclusion

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 assure the efficient completion of this step, usually within 48 hours.

About the Authors:

Allan Valmonte is the Senior Director of Business Development at goBalto and has over 12 years of biopharmaceutical drug development experience. He served as a clinical research consultant for KAI Pharmaceuticals and StemCells, Inc., and held positions in clinical research and development at OXiGENE, Cerexa, and Telik. He has also worked on early, late, and post-approval programs for Integrilin® (Millennium), Vectibix® (Amgen), Lipitor® (Pfizer), and Xolair® (Genentech). Allan holds a B.A. in psychology from California State University, Hayward.

Erik Sam is the Senior Director of Customer Development at goBalto and began his career as an engineer in the Process Research and Development department at Genentech, Inc. There he developed and optimized manufacturing processes in Late Stage Purification for numerous products entering clinical trials. He also ran successful GMP campaigns and collaborations with outside vendors to develop new technologies for the entire biotech industry. Erik holds a B.S. in chemical engineering, with a focus in biotechnology, from the University of California, Berkeley.

Dan Manak is a graduate of the University of Wisconsin – Madison. After earning his bachelor of science degree in Molecular Biology he began his career in pharmaceuticals with Hoffman-La Roche, holding positions in sales, sales management, and training. He has worked in pharmaceuticals, health care, and clinical research for over 20 years with Fortune 100 companies as well as start-ups. For the past seven years he led a small clinical research service organization as the President and Director of Business Development. His expertise and passion exist specifically in the area of clinical study start-up, having worked on several hundred protocols and initiating close to a thousand investigative research sites. In his spare time, Dan is a volunteer EMT and martial artist/Instructor.

About goBalto: goBalto is a small team that creates simple, focused and affordable web based software for the global clinical trial industry. Our products offer drug trial sponsors the easiest possible way to start their clinical studies on the web, which makes them feel better. www.gobalto.com