5 Steps to Securing a Clinical Trial

Your site has been contacted about a new clinical trial opportunity. Now what? These 5 steps to securing a clinical trial will contribute to a streamlined trial procurement process and enhanced relationships with pharmaceutical and device companies.

  1. A streamlined confidentiality document process
  2. The confidentiality disclosure agreement (CDA) is required by the sponsor before the hospital will receive any study specific information. This agreement binds the hospital to keep the trial information confidential. To ensure the information or language required by your hospital is included in the agreement, it is a best practice to create a checklist with these points to follow while reviewing the CDA. If you must work with the legal or other department, it is a good idea to ask for a dedicated point of contact to ensure timely turnaround of the agreement. Finally, once the language has been agreed upon by all parties, obtain all necessary signatures and return the executed agreement to the sponsor within two business days.
  3. A careful evaluation of the study protocol
  4. The protocol review is probably the most important step in the process for your site. It is recommended you create a second checklist of important details to consider when reviewing the protocol to determine if the study is a good fit for the hospital.
  5. Communication during the feasibility questionnaire process
  6. The feasibility questionnaire is the pharmaceutical or device company’s chance to ask about the specific capabilities of the hospital and make sure the hospital is able to follow the study protocol compliantly. It is important to stay in contact with the study sponsor during this sometimes-long step in the process to demonstrate your hospital’s interest in the study.
  7. An organized site qualification visit
  8. If the sponsor is pleased with the information gathered during the questionnaire process, they will visit the hospital to verify the information and meet with people in departments who will be involved in the study. Show the sponsor that your site has the experience and capabilities to run the trial. Preparation and organization will ensure a smooth pre-study visit.
  9. And Prompt follow up
  10. The process to secure a clinical trial doesn’t end after the pre-study visit. You still need to get the award letter and follow up is key—be sure to respond promptly to any sponsor questions or requests for additional information.

    GuideStar Staff

    Post by GuideStar Staff

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