Essential Document Storage Location

Clinical Trial Name:

HREC Ref: Local Ref:
Documents Storage Location Notes
HREC Paper Electronic Not
Notes
Submission/approvals Site File Site file Applicable
Original protocol/amendment
Initial Approval from the
☐ ☐ ☐ signature pages must be maintained
Ethics Committee (HREC)
in the Site File
Protocol Amendment
approval documentation ☐ ☐ ☐
from HREC
Annual Reports/submission
☐ ☐ ☐
and acknowledgement
Submission /
acknowledgement of ☐ ☐ ☐
Investigator’s Brochure
Acknowledgement of safety
☐ ☐ ☐
reports/DSMB letters
Other ☐ ☐ ☐
Paper Electronic Not
Governance Approvals Notes
Site File Site file Applicable
Site Specific Approval ☐ ☐ ☐
Amendment
☐ ☐ ☐
acknowledgements
Other ☐ ☐ ☐
Investigator Qualification Paper Electronic Not
Notes
Documentation tab Site File Site file Applicable
2 page CVs to be updated every 2
CVs for all investigators ☐ ☐ ☐
years
TransCelerate Accredited courses
ICG GCP Training ☐ ☐ ☐
valid for three years
Paper Electronic Not
Investigator’s Brochure Notes
Site File Site file Applicable
Investigator’s Brochure (IB) ☐ ☐ ☐

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 Paper Electronic Not
Regulatory Documents Notes
Site File Site file Applicable
Clinical Trials Research
☐ ☐ ☐ Original signed copy must be kept
Agreement (CTRA)
Indemnity Form ☐ ☐ ☐ Original signed copy must be kept
Insurance Certificate ☐ ☐ ☐
eCTN Sponsors responsibility to supply
☐ ☐ ☐
acknowledgement/Receipt eCTN receipt to the site
Financial Disclosure Forms Paper Electronic Not
Notes
tab Site File Site file Applicable
Signed Financial Disclosure
☐ ☐ ☐
Forms (if IND)
Paper Electronic Not
Study Communication tab Notes
Site File Site file Applicable
All communication related
to the conduct of the
☐ ☐ ☐
protocol and agreements
with scientific collaborators
Memos to File documenting
important decisions ☐ ☐ ☐
regarding study conduct
Delegation of Paper Electronic Not
Notes
Responsibilities Log Site File Site file Applicable
Original signatures must be stored
Delegation of in the Site File . An electronic
☐ ☐ ☐
Responsibilities Log version may be maintained in
addition to the original log.
Clinical Research and Study Paper Electronic Not
Notes
Training tab Site File Site file Applicable
Documentation of study- Site initiation meeting/PowerPoint
☐ ☐ ☐
related training presentations
The Training Log must be
maintained using a paper log or
Training Log ☐ ☐ ☐ electronically. Ensure confirmation
of training is received either via
email or dated signature
Screening/Enrollment Log Paper Electronic Not
Notes
tab Site File Site file Applicable
Subject Screening Log ☐ ☐ ☐
Subject Enrollment Log ☐ ☐ ☐

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 Paper Electronic Not
Signed Consent Forms Notes
Site File Site file Applicable
Original consent documents must be
All original signed consent maintained by the site; a copy is
☐ ☐ ☐
documents given to the participant or person
responsible (if applicable)
Paper Electronic Not
Supporting Departments Notes
Site File Site file Applicable
Investigational Product Pharmacy generally is responsible
Accountability Log: Stock ☐ ☐ ☐ for the maintenance of this under
Record the supervision of the PI
Investigational Product
Accountability Log: Subject ☐ ☐ ☐
Record
Other ☐ ☐ ☐
Local Clinical Lab
Paper Electronic Not
Certificates / Reference Notes
Site File Site file Applicable
Ranges tab
Contact SSWPS coordinator for
Lab reference ranges ☐ ☐ ☐ updates versions NSWPATH-
SWSTrials@health.nsw.gov.au
Copy of certifications and
☐ ☐ ☐
accreditations
Paper Electronic Not
Specimen Tracking Log Notes
Site File Site file Applicable
Specimen Tracking Log ☐ ☐ ☐
Other ☐ ☐ ☐
Paper Electronic Not
Source Notes Notes
Site File Site file Applicable
Participant Folder ☐ ☐ ☐
Clinical Information/Medical
☐ ☐ ☐
Notes
Imaging (X-ray,CT scan,MRI
☐ ☐ ☐
etc.)
Haematology/Biochemistry ☐ ☐ ☐
Other ☐ ☐ ☐

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 Serious Adverse Events Paper Electronic Not
Notes
(SAEs) and SUSAR reporting Site File Site file Applicable
SAE and SUSAR
reports/documentation and ☐ ☐ ☐
reporting
DSMB Letters ☐ ☐ ☐
Other ☐ ☐ ☐
Paper Electronic Not
Protocol Deviations tab Notes
Site File Site file Applicable
Protocol Deviation
☐ ☐ ☐
Forms/Reports
Protocol Deviation Tracking
☐ ☐ ☐
Log
Clinical Site Monitoring Paper Electronic Not
Notes
Visits tab Site File Site file Applicable
The Monitoring Visit Log must be
Monitoring Visit Log ☐ ☐ ☐ stored in the Site File and contain
original signatures.
Relevant Correspondence
between site and ☐ ☐ ☐
CRO/Sponsor
Paper Electronic Not
Other tab Notes
Site File Site file Applicable
Newsletters ☐ ☐ ☐
Other relevant
correspondence relating to
☐ ☐ ☐
the management of the
clinical trial
Site closure reports ☐ ☐ ☐
Archiving ☐ ☐ ☐
Other ☐ ☐ ☐

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