Research Recordkeeping. Carole A. Hamon & Danna Carver Research Support and Regulatory Affairs 501-526-6876. Introduction . Accurate documentation of research activities is not an option Incomplete record keeping yields data that is neither valid or reliable
Carole A. Hamon & Danna Carver
Research Support and Regulatory Affairs
Protocol and CRFs
Approved by IRB
Research Activity Recorded in Permanent Record
Research Staff Copy
Data to CRFs from Source
CRF Data is Monitored
Data is Analyzed and
Regs available at
If it was not documented, it was not done.
An investigator is required to prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation.
Case histories include the case report forms and supporting data…signed and dated consent forms, any medical records, …progress notes…,the individuals hospital chart(s), and nurses notes. The case history for each individual shall document that informed consent was obtained prior to participation in the study.
Original documents, data and records (e.g. hospital records,clinical and office charts, laboratory notes, memoranda, subjects’ dairies or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate and complete, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the –pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial)
--Antonio El- Hage
Branch Chief, GCPII FDA
*Not an option
Direct quote from an FDA letter:
“Failure to maintain adequate and accurate case histories [21 CFR § 312.62(b)]
You failed to ensure that data required on the Case Report Forms (CRFs) was transcribed from the study records…”
Each subject must have a unique record for each step of the research. It should contain:
Reports must be sent to the IRB AND the Sponsor. Keep a copy of those in the file, along with the record of when they were sent.
An Investigator is required to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects.
CFR 21 part 312.62a
Includes prescribing and accounting for returned or unused drugs or devices.
...any drug for human use, biological product for human use, medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the Public Health Service Act.
CFR 21 part 56.102(l)
*Should be listed as “key study personnel”
On the signature log