Few years ago a nurse working on clinical trial contacted me to ask about simple instruction on how to send X-ray images to external vendor. I sent her e-mail with 5-step instruction and attached the form she needs to complete. She rang me few minutes later and said, “This is brilliant! But if it is so simple why there is a 40 page manual for this?” This is indeed a valid question.
There are lots of different manuals in clinical trials and all of them are quite extensive and detailed. Vendors always try to include as much as possible information and cover all possible questions but the result is a huge manual that clinical trials teams do not have time to read.
What are the common problems with manuals?
- Vendor training provided is too long and with too many details and clinical trials teams do not remember all requirements.
- When the study is initially set up there was not enough training provided during the site initiation visit.
- Vendor support team is not providing adequate guidance on specific questions and often refers clinical trials teams to the manual provided.
- During the initial set up clinical trials teams have to go through hundreds of pages to find out how to ship lab samples, register patients in IVRS, enter data, send images, etc. This is very time-consuming process.
- When a team member is not at work or has left, the new team member has to spend the same amount of time to go through all manuals to identify what is required.
What can be done to safe time for clinical trails teams?
1. Ask the vendor support team to provide simple step-by-step instruction for the procedure. This is their process so they should be able to explain what is required.
2. Keep simple instructions in a study specific folder on your server so your colleagues could find it easily if needed.
3. Once you have gone through the process create a simple procedure that could be used by the whole team.
4. Ask your administrative support to help create a simple procedure.
5. Communicate the procedure to your colleagues.
6. Check if there is a simple way of doing things – is it possible to send the required information online which will be easier and faster?
7. Do not forget to add any specific tips or requirements.
Author: Olga Peycheva
Olga is a clinical research professional who has been working in clinical research since 2005. She has extensive experience in clinical research in Eastern and Western Europe.
Originally published on 12 July 2014