August 2024 SOCRA Source Journal - Journal - Page 31
REDCap also can be used as an
e-consent database. Templates
have been implemented at
various institutions; however,
some do not have a place for
the person obtaining informed
consent to sign the form. For
the e-consent instance that the
author built, there was one form
that was the main informed
consent form, with language
mirroring the paper consent,
where the participant or the
legally authorized representative
sign. The representative or
participant reviews the form
and signs it electronically 昀椀rst.
Then whoever is consenting
opens another survey that
is just a signature block and
signs it as the person obtaining
informed consent. Both forms
are stamped with the time and
date and the system emails the
signed documents to the legally
authorized representative.
The REDCap e-consent
template is not compliant with
Title 21 of the Code of Federal
Regulations Part 11, Electronic
Records; Electronic Signatures
for FDA-regulated clinical
trials. For this study that is not
a requirement since it is an
observational study and not a
clinical trial. The IRB was made
aware there are two separate
forms (one that is the informed
consent form for the legally
authorized representative or
participant to sign and the other
form for the clinical research
coordinator. The forms look
identical to the IRB-approved
document.
As the project manager and
monitor for the 12 clinical
sites, when the author checks
the informed consent forms,
she reviews the timestamp to
ensure that the clinical research
coordinator is signing the form
within hours of the legally
authorized representative/
participant signing; that the
names are appropriate; that the
legally authorized representative
did not write their name on the
form as the participant; that
dates and time stamps predate
any research procedures; etc.
For this study REDCap includes
a 昀氀ag that does not allow the
sites to enroll participants until
the informed consent form has
been signed.
Using direct date entry, clinical
research coordinators type
information from the legally
authorized representative
participant/participant into
REDCap as they are conducting
the interview or collecting the
data. The parents also can
receive surveys to complete via
the platform. This can be done
on a mobile device, tablet, or
remotely at home.
All documents kept in a paper
binder can be kept in an
electronic binder (Table 5).
Electronic binders can be stored
in an electronic clinical trial
management system or on a
shared drive such as Microsoft
OneDrive. OneDrive is utilized
for this U grant. The SOP
speci昀椀es where the documents
are stored electronically.
The author monitors the 12
clinical sites in the U grant
biannually, as per National
Institute for Dental and
Craniofacial Research’s
requirement. She uses their
monitoring templates and
modi昀椀ed them for use in
REDCap. They are available on
their website for free download.
TABLE 5
Sample Regulatory
Binder Contents
•
•
•
•
•
•
•
Protocol
IRB submissions and
amendments:
o IRB roster
o IRB applications
o Serious adverse
events and
unanticipated
problem
Consent documents
Case report forms and
questionnaires
Recruitment materials
CVs and licenses
Training
The sites do self-monitoring
昀椀rst and then the author
monitors the sites separately
to ensure accuracy.
Key Takeaways
1. An FDA investigator is
not a “friend,” as their
role dictates a different
relationship.
2. Monitors are bene昀椀cial, as
you work together to ensure
a study is compliant and
well documented.
3. Along with preparing the
subject 昀椀les and regulatory
binder for an inspection, it is
also necessary to obtain and
collate information on the
investigational product for
an IIR.
4. SOPs and documentation
are crucial. Anything that
is not documented did
not happen.
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