ABSTRACT
Case Report CRFs should be completed immediately after a subject’s visit. Forms Some pages may be completed during the study assessment visit.
In this case, make sure that adequate documentation is available in the subject’s medical record/clinic chart. Don’t let the site neglect completion of the CRFs. Insist that the CRFs be current at the time of each monitoring visit so that the CRA can review all of the data. The site staff may also have to make copies of the CRFs or separate NCR (no carbon required) papers while submitting the data to the sponsor. The sponsor may require that data on CRFs be faxed directly to them in order to expedite data entry and analysis. Assure that the site has allotted time for the CRC to dedicate for this ESSENTIAL process.
