Follow us on

Q of the week

Q: How Do You Get Shingles?

Get the Answer: 

Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.
Consent of Investigator/1572 and CVs
  1. If any of the sub-investigators are out of the study, should the FDA 1572 form be updated to reflect this change?
    No, FDA form 1572 need not to be updated if any of the Sub-Investigator is out of the study. Only signature need to take on the delegation of the authority log reflecting the sub-investigator is out of the study. Note: If the Sub-investigator is replacing with the new sub-investigator then you need to update (supersede) previous 1572.
  2. The ICH Guideline on study reports, section 16.1.4 states that a 'list & description of investigators and other important participants in the study, including brief CV or equivalent summary of training....' should be included. Who are 'other important participants'?
    The people who are signed up as sub-investigators and have delegated tasks, e.g. study nurses should be included. And those staff performing specific trial tasks with delegated responsibility should be included, but that those staff that perform a function that it part of their normal job need not be included. For example, a person who takes a blood sample, unless it has to be taken in a special way, would not be included, but the head of the lab who analyses it would be included if he/she is taking responsibility for the results of the analysis.
  3. Collection of CVs from whom?
    This will depend on your company SOPs, but in general, principal and sub investigators, heads of labs, pharmacy, radiology, etc. if contributing data to the study. Other staff CVs not generally collected if they are performing routine tasks, but if a special assessment made in the trial, CVs should be collected from the staff performing it to demonstrate training to perform that special task. Copies of Registration documents of, for example, radiographers, can be useful to demonstrate competency.
  4. When doing an FDA regulated trial, should all CVs of site personnel be submitted with the 1572 and can they be photocopies?
    The CVs of the investigators, co-investigators and any personnel making decisions during the trial should be sent with the 1572. The CVs (including that of the principal investigator) do not need to be originals, photocopies are acceptable.
  5. If you’ve got a trial that’s going on for a very long time, say five years, do you require the CVs to be updated during this time or are the original CVs provided at the beginning of the study satisfactory?
    It would depend on what other documentation is maintained to record relevant training and experience. If the company policy is for company staff to keep good training records to document how staff knowledge has been updated and how they have been trained for specific tasks, then it may not be necessary for the CV to be updated as well.
  		 


Opinion Poll

Which one of the following do you think is the most common reason for participating in clinical trials?
 
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.
There are no events at this time

Links