SOCRA CCRP QUESTIONS AND ANSWERS
How long is the reporting period for equity interest and significant payments? Correct Answer:
study period plus one year
Pre-Study Documents (Essential Documents) Correct Answer: FDA 1572 (drug) or signed
investigators agreement (devices) CVs, licenses, ect
Fully executed contract and budget Protocol signature sheet
Approved informed consent LAB certificates (Clia and CAP) and normal values
Lab director's CV IRB membership and assurance #
IRB approval
SMO Correct Answer: site management organization - Companies contracted with by the
sponsor to find and manage the sites conducting the study.
study period plus one year Correct Answer: how long is the reporting period for equity interest
and significant payments
510K clearance Correct Answer: Established in 1976
-Most devices (90%) are marketed as 510(k)s- meaning that the sponsor can provide data that
device is comparable to an already approved device
-Mostly class I and II devices
-FDA applies "clearance" NOT approval
biologics licensing Correct Answer: application for approval from FDA is a PLA, for biologics
is a BLA. Application submitted to Biologics evaluation and research. Application includes data
derived from non-clinical laboratory and clinical studies which demonstrate that the
manufactured product meets prescribed requirements of safety, purity, and potency. Approval of
a BLA or issuance of a biological license shall constitute a determination that the establishment
and the product meet applicable requirements to ensure the continued safety, purity and potency
of such products.
How long is the reporting period for equity interest and significant payments? Correct Answer:
study period plus one year
Pre-Study Documents (Essential Documents) Correct Answer: FDA 1572 (drug) or signed
investigators agreement (devices) CVs, licenses, ect
Fully executed contract and budget Protocol signature sheet
Approved informed consent LAB certificates (Clia and CAP) and normal values
Lab director's CV IRB membership and assurance #
IRB approval
SMO Correct Answer: site management organization - Companies contracted with by the
sponsor to find and manage the sites conducting the study.
study period plus one year Correct Answer: how long is the reporting period for equity interest
and significant payments
510K clearance Correct Answer: Established in 1976
-Most devices (90%) are marketed as 510(k)s- meaning that the sponsor can provide data that
device is comparable to an already approved device
-Mostly class I and II devices
-FDA applies "clearance" NOT approval
biologics licensing Correct Answer: application for approval from FDA is a PLA, for biologics
is a BLA. Application submitted to Biologics evaluation and research. Application includes data
derived from non-clinical laboratory and clinical studies which demonstrate that the
manufactured product meets prescribed requirements of safety, purity, and potency. Approval of
a BLA or issuance of a biological license shall constitute a determination that the establishment
and the product meet applicable requirements to ensure the continued safety, purity and potency
of such products.
