So lately there has been so much buzz around the announcement of pharma companies sharing their Investigative Site databases in order to shorten clinical trial study start up times by getting rid of redundant procedures. This blog post will bring attention to the Top 5 most important clinical trial study start up procedures that exist in my own opinion. While not all of these are redundant, some will perhaps be eliminated as once a year activities as opposed to being required prior to the start of every clinical trial as is currently the case.
1.) GCP/other training- Good Clinical Practice is no doubt required training for any researcher. However, doing this same training for every study is redundant. Once a year GCP training is currently the industry standard, and prior to these collaborations we are discussing above, most researchers are doing several GCP trainings each year.
2.) IRB questionnaires- This is still unclear as to how this will be streamlined, if at all, but every clinical trial needs IRB approval. Most research clinics can use central IRB’s which make the process easier, while others are required to utilize local IRB’s. Check this video on the differences between these two. Regardles of which type of IRB being utilized, IRB questionnaires are time consuming and usually ask the same information study by study, so it will be interesting to see whether this activity can get streamlined once the Pharma collaborations get underway by the end of this year.
3.) Regulatory document preparation- While this activity is study specific and probably can never get streamlined like the previous two activities, regulatory document preparation of the 1572 form, financial disclosure forms, IRB forms, Informed Consents, and gathering plus submitting all the researcher CV’s is required for clinical trial site activation.
4.) Informed Consent Creation- This activity is also study specific and study details such as subject compensation, IRB contact info, emergency 24 hour contact information, etc must be entered by the research site prior to receiving IRB approval and site initiation.
5.) Creating Source Documents- Most of the time, the research site must create the actual forms for which all the required study data will be collected on. This sounds like a simple task, but for anyone who has done any of this, they know it is extremely time consuming. We had a guest blogger write an excellent article on creating source documents here.
While these are certainly not the only clinical trial start up activities, I believe they are some of the most time consuming ones. It is also important to keep in mind that these activities should not be done by the research clinic for free. Tips on how to bill the sponsors for these activities can be found in this video interview.