November 2024 SOCRA Source Journal - Journal - Page 37
JOURNAL ARTICLES
Proper Documentation
of a Clinical Trial: What Are
All These Forms and How
Do I Complete Them?
Laura Adkins, MAP, CCRP, CCRA, CRS, AdvCRS
Director, Of昀椀ce of Research Regulatory Affairs,
University of Arkansas for Medical Sciences
Laura Adkins, MAP, CCRP, CCRA,
CRS, AdvCRS
Abstract: From Case Report Forms to Screening-Enrollment, Delegation of Authority, Adverse Events, Deviation,
and Investigational Product Accountability Logs, there is a lot of information to be transcribed when documenting
a clinical trial. Both new and experienced clinical investigators and study team members often have many questions
when it comes to 昀椀lling out these essential forms. When the regulations are silent, IRBs, Institutions, Sponsors,
Contract Research Organizations (CROs), and clinical investigators are free to develop their own procedures and
practices as long as applicable regulatory requirements are met. However, certain elements should be taken
into consideration when determining how to record data with integrity (reliable, accurate, complete, consistent,
trustworthy, in context). This article presents background information on why the forms are needed and guidance
on how best to complete them to comply with regulations and “best research practice”.
Introduction
Although much of our work
these days is achieved through
electronic means, it still very
often feels like we are “buried”
under mountains of documents,
whether those be in paper
on our desk or pending our
attention in email or in electronic
data capture (EDC) or medical
record systems.
The quality of a study and
ultimately its results will be
determined by the completion
and then review of various forms
and logs 昀椀lled out by the study
team, so proper documentation
is vital to a study’s overall
success. If you 昀椀nd paperwork
(whether paper or electronic) to
be tedious, research may not be
the right 昀椀eld for you!
Informed Consent Form
Informed consent is the primary
ethical requirement underpinning
research involving humans,
therefore, the informed consent
form (ICF) is inarguably one of
the most important documents
completed in a clinical trial.
However, informed consent
is not simply a signature on a
document, it is a process that
continues throughout the subject’s
participation. U.S. Food & Drug
Administration (FDA) regulations
and Good Clinical Practice
(GCP) guidelines contain speci昀椀c
guidance and instruction on this
essential piece of the research
puzzle and very often, clinical
research sites will have their own
Standard Operating Procedures
(SOPs) involving this process.
Initial informed consent must be
obtained prior to performance
of any clinical procedures that
are done solely for the purpose
of determining eligibility for
research. Re-consent may be
necessary during the study
period (e.g., when an ICF is
updated with new information
regarding risks and/or bene昀椀ts).
It should be determined by
an Institutional Review Board
(IRB) (or in some cases, the
Sponsor), whether subjects
who are still active on the study
should be re-consented. In
the author’s experience, the
“willingness to participate”
method can be used to make
this determination, that is,
would updates make subjects
less willing to continue in the
study (e.g., increase in number
SOCRA SOURCE © November 2024
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