Maintaining and storing the essential regulatory documents is an important practice in clinical research. The proper filing and organization of these documents can greatly improve a clinical trial management. Usually, Regulatory Documents will be stored in a binder (or binders) that’s provided to the site for that specific study. Filling out these documents and filing them properly is the site’s and especially the PI’s responsibility. Storing them properly is also the site’s responsibility, not the CRA’s. In any case, after the study is over, the sponsor or the CRO will inform the site if they should keep the originals or make copies of the Regulatory Documents for storage. Similarly, the sponsor or the CRO will also tell the site how long they need the documents to be kept and stored on-site.

1. Essential Regulatory Documents
in Clinical Trials
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2. Introduction
Maintaining and storing the essential regulatory documents is an important
practice in clinical research. The proper filing and organization of these documents
can greatly improve a clinical trial management. Usually, Regulatory Documents
will be stored in a binder (or binders) that’s provided to the site for that specific
study.
Filling out these documents and filing them properly is the site’s and especially the
PI’s responsibility. Storing them properly is also the site’s responsibility, not the
CRA’s.
In any case, after the study is over, the sponsor or the CRO will inform the site if
they should keep the originals or make copies of the Regulatory Documents for
storage. Similarly, the sponsor or the CRO will also tell the site how long they need
the documents to be kept and stored on-site.
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3. Defining Essential Regulatory Documents
The term ‘’essential documents’’ refers to the documents
which, according to the ICH-GCP Guidelines, serve to
evaluate the trial conducted, data quality and integrity.
These documents are contained in the Trial Master File
and are otherwise known as Regulatory Documents. Such
documents are usually the important agreements,
contracts, delegation logs, training logs, etc.
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4. Most Important
Regulatory Documents
There are many essential Regulatory Documents in a clinical trial.
In the next few slides, we’ll give examples and explain some of
the most important documents for a clinical research site.
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Most Important Regulatory Documents
previous protocols
current protocol protocol
amendments
Form FDA 1572
IRB approvals
IRB
correspondence
site visit
(monitoring) log
subject visit log
CDAs
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Most Important Regulatory Documents
list of subjects ID
codes
screening and
enrollment log
HIPPA forms
IP-related
documents
protocol
deviations
training logs
informed
consent forms
ads and marketing
materials
IND safety
reports
CFRs
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Form FDA 1572
(Statement of Investigator)
According to 21 CFR
312.53(c):
The Form FDA 1572,
otherwise known as the
Statement of Investigator,
is one of the most
important documents in a
clinical trial because it
shows the sponsor that
the PI (principal
investigator) will comply
with all FDA regulations.
The Statement of
Investigator also provides
the sponsor with all
necessary information and
data of the investigator
such as education, past
experience, training, site
addresses, IRB forms,
facility locations, etc.
“No investigator may
participate in an
investigation until he/ she
provides the sponsor with
a completed, signed
Statement of Investigator,
Form FDA 1572.”
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Confidentiality Disclosure Agreement (CDA)
The second important Regulatory Document is
the CDA which has to be completed and filled
out by the site or PI.
The purpose of this agreement is to ensure
that all trial-related information and data is
protected and secured. The CDA represents a
legal document which binds everyone working
at that site to secrecy and privacy. Anything
connected to the trial should stay private.
An example of this is the Investigator Brochure,
protocol synopsis, the full protocol, etc. These
things and all other intellectual property of the
Sponsor/CRO should stay confidential, thus the
need for a CDA.
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Financial Disclosure Forms (FDFs)
All investigators listed on the Form FDA 1572
are obliged to fill out an FDF.
The purpose of the FDF is to check if any of the
investigators have a financial interest or
expectation from the study. When such an
interest exists, the investigators are obliged to
state the amounts, arrangements, and
payment schedules and timelines as well as
ways in which the investigator and the site will
avoid or minimize the potential for bias.
And finally, the FDF should contain the
maximum number of monetary or equity
amounts that the investigator is allowed to
receive for the trial.
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$
Investigator’s
financial interests

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Training Logs &
Protocol Signature Pages
Anyone who attends protocol training and all other
amendment trainings should sign these documents.
Afterwards, the PI should also sign these documents
as a confirmation that he/she managed to properly
train other site staff.
As we all know by now, the PI is responsible for
conducting a study that will adhere to the
given protocol as well as comply with all FDA
and GCP guidelines and regulations. This
means that it’s the PI’s job to train and
educate site employees on the protocol. For
this reason, Training Logs and Protocol
Signature Pages exist.
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Delegation of Duties Log
As you can imagine by the name, the Delegation
of Duties Log serves exactly that purpose – states
which duties the PI delegated to whom.
At a site, it’s important that everyone knows their
own tasks. In order to achieve this and make the
job more efficient, the PI will delegate duties and
roles to each person according to their
experience and education. Each study-specific
task that an individual performs should be noted
in this log, and at the end, the PI signs off as an
approval of the delegated roles.
The Delegation of Duties Log usually includes the
first name and last name of the person
performing a task, the role or the task itself, the
signature of the individual, the start and end
date, and other similar details.
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nurses/
other staff
sub-Iscoordinator
PI Delegation of Duties

12. PAGE 12
The E-signature is just as valid as a
handwritten signature. For this reason, all
investigators should respect the concept
of password confidentiality and e-
signatures. Understanding the
importance of E-signatures is important
for many reasons, the most important
being that it’s still a legally binding
signature.
Password Confidentiality & E-signatures
There are many tasks throughout a
trial that will require an E-signature,
such as signing off on e-CRFs
(electronic case report forms). These
forms belong in the EDC (electronic
data capture) system and signing off
on them shows that the data entered
there fits the original source
documentation.

13. IRB Correspondence
Central IRB
Deals with independent
clinical research sites.
Local IRB
Deals with University or
Hospital clinical research
sites.
As we all know, IRB stands for Institutional Review Board. All documents related to the IRB and all correspondence should be considered
important and essential. IRB correspondence is usually closely connected to subjects’ safety and well-being and conducting the trial according to
FDA and GCP rules and regulations. Having into consideration that the subjects’ safety is the most important thing in a trial, it’s understandable
why these IRB documents are crucial. The job of the IRB is to make sure that the site has the appropriate PI, staff, and capabilities to be able to
safely conduct the trial. They are concerned with the PI’s oversight, his/her experience, qualifications, number of studies he’s conducting at that
given time, etc. All of these things are monitored in order to ensure maximum protection and safety of the participants. The IRB that’s responsible
for a site can be Central or Local. Usually, local IRBs take only University or Hospital sites. So, if your site is an independent one, you’ll probably be
dealing with central IRB. All in all, the IRB is there to decide whether or not the site is capable and equipped to conduct an ethical trial.

14. Note-To-Files (NTFs)
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No site can conduct a trial without any errors or
mishaps. So, whenever something happens that needs
a further explanation or clarification, Note-To-Files are
the perfect tool for that.
Sometimes, there are unpredictable problems,
deviations, or discrepancies that cannot be explained
and noted anywhere else in official documents.
Anything that happens on site that needs further
clarification can be noted though Note-To-Files.
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Although this might seem as additional and
unnecessary documentation to take care of,
sometimes it’s the only legal and correct way to
justify an action that happened on site.
For example, a protocol deviation might have
occurred by mistake or it might have been necessary
because it was connected to a patient wellbeing and
safety. This is where NTFs can help you explain
yourself.

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CONCLUSION
The above-mentioned documents are only a portion of all essential regulatory documents that everyone involved in clinical research
should be familiar with.
Being aware of the importance of these documents will help you conduct a better and more organized clinical trial. Properly managing
and storing these documents in a timely and accurate manner is crucial for every sponsor and FDA audit.
And finally, doing this will ensure that the final results and data of the trial are produced with quality and integrity.
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