Although screening holds will soon be lifted and sites are eager to return to business as usual, the risk of COVID-19 is still very real for many Americans. It is imperative that sites take precautions to lower the risk to their study subjects and staff. The last thing anyone wants is to be inundated with SAEs, subject withdrawals, and staffing shortages. Best practice is to minimize the time a subject spends on-site. The question is how to do this while staying within FDA and IRB guidelines.
One way is to implement thorough pre-screening of subjects, for both study specific eligibility criteria and COVID-19. It is within guidelines to ask subjects for information regarding their health, if you submit the script to the IRB with adequate description on how sensitive subject data collected (personal, medical, financial) is being used and will be protected.
I would also consider restructuring screening visits to include remote procedures. If all procedures are completed within the screening window, there is no reason a screening visit cannot be split into multiple parts. At the very least, the ICF, medical records release, medical history, concomitant medications, and questionnaires can be collected remotely, as long as you properly confirm the identity of the subject prior. Subjects can then be scheduled for an onsite visit for vitals, ECG, labs, and any other clinical screening procedures. This will expedite the study visit and the subjects will appreciate how seriously you are taking their health into consideration, improving retention.
There are many avenues to obtain consent electronically in a remote setting, either in place of paper or as supplementation to paper. Double check your local guidelines along with the FDA Guidelines before implementing eConsent. Also, do not be afraid to amend the ICF to match your site’s SOPs and resubmit for IRB approval. For instance, if it is expected that subjects wear a face mask to all study visits, that expectation needs to be documented along with the subject’s understanding and agreement.
This is an unprecedented time, and the key to getting through this successfully is communication and documentation. Keep your subjects and sponsors informed of any change to standard operating procedures/ study specific procedures and document the exchange. We are all in this together!