First of all, in my opinion, you made a really well-organized CRF, and it is quite easy to follow with all necessary parts already there. I might not have many comments for you because it is already a great work. Please find some of my suggestions for the improvement below,
Your CRF has all important IDs, including Study ID, Subject ID, and Site ID, but one thing to add is the CRF version and date. This can help track the specific version of the CRF and ensure every site uses the same version to maintain consistency.
– Instructions Part
The CRF included instructions part which I missed this in my CRF which is very important. Without this part, recorder might misunderstand how to respond, causing inconsistent data. Actually, if this part was not included, I might tick the correct sign in every box. It’s good to learn from your work! One thing that might help if it is a paper CRF, as your CRF already has instructions, you can add an item about the use of permanent media (blue or black ink).
-Screening Part
You have complete information on both inclusion and exclusion criteria. The options given for both parts are clear with yes or no. However, to add more accuracy in pregnancy tests, a “not done” option might be needed to show that the pregnancy test was intentionally not performed rather than accidentally omitted or overlooked.
– Enrollment Part
You have provided a good quality design. The demographics part is easy to follow and respond to since you have added the “unknown” or “no response” option to avoid errors. For the vital signs part, you have clear guidelines such as decimals and digits, and it is all in separate boxes. well done!!
The physical examination section is also complete, but in some parts, it may need to specify details if abnormalities are found (in the last column), such as in the skin, EENT (Eyes, Ears, Nose, and Throat), head, and some other areas. Adding blank spaces (…………) in the last column can guide recorder to fill the breif more specific information in case of abnormal.
Overall, your CRF is perfect.!! I learned a lot from reviewing your work and it gives me a great chance to know how to improve my CRF!! I hope my little comments may help and Thank you!!.