Medidata Blog

Protocol Interpretation: Is There a Better Way?

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I have spent a significant portion of the last 12 years reading study protocols in an attempt to distill details that are pertinent to the design of randomization and trial supply management solutions. Every time I read a protocol, I build up a picture of the study asking questions like:  

  • How are subjects randomized to treatment?
  • Are there any controls imposed on successive subjects being enrolled into the study?
  • When are subjects assigned trial medication?
  • How is the investigational product packaged in order to maintain the blind and to service the treatment needs of a subject?
  • By what criteria are subject's dosed with trial medication?
  • Does the site require any instructions as to how to dose a subject, whilst maintaining the blind?

I distill the answers to these questions to form requirements for the solution. I have found that this sometimes becomes a question of interpretation and guesswork, because protocols are not always written in a consistently unambiguous way. And furthermore, some of the information I need is sometimes absent from the protocol and needs to be gathered from other sources, like asking a sponsor clinical supplies manager, for example.

Wouldn't it be nice if we could take the guesswork out of protocol interpretation? Additionally, wouldn't it be nice if we could remove the redundant step of reading and interpretation on the one hand and just let the solution requirements flow out of the protocol in an automated, structured way? Some in the industry have moved toward a standardization of the information that would be contained in a structured protocol.

What is stopping us from doing this?


Jacob Angevine