Study Document Archival Inventory

Version No: 1.0 / Clinical Research Centre / Page 1 of 8
Date: dd/mm/yyyy / Study Archiving Inventory Form / WS-G-4-02-03

Property of CRC

May not be used, divulged, published or otherwise disclosed without the consent of

The Director, Clinical Research Centre

STUDY ARCHIVAL INVENTORY FORM
Study Title: / <Insert title> / Protocol Number: / <Insert protocol number
Principal Investigator: / <Insert PI’s name / PI Contact: / <Insert PI’s telephone number
Site Principal Investigator: / <Insert Site PI’s name for multicentre trials / Site PI Contact: / <Insert site PI’s telephone number
Site PI’s Address: / <Insert Site PI’s address
Sponsor: / <Insert sponsor’s name / Sponsor Contact: / <Insert sponsor telephone number
Sponsor Address: / <Insert sponsor’s address

Are the following study documents archived at study site:

(If the answer is ‘No’ to any of the items below, specify reason(s) in ‘Comments’)

MREC/IRB and Protocol

Yes /

Box #

/ No / NA / Comments
MREC/IRBapproval letter / Insert number / Insert comment
MREC/IRB correspondence/composition / Insert number / Insert comment
Approved protocol / Insert number / Insert comment
Approved protocol amendments / Insert number / Insert comment

CV and Agreement

Yes /

Box #

/ No / NA /

Comments

CV of site PI and all co-Investigators / Insert number / Insert comment
Investigator’s agreement / Insert number / Insert comment
Financial agreement / Insert number / Insert comment
Signatures and Authorisation Sheet / Insert number / Insert comment

Laboratory

Yes /

Box #

/ No / NA / Comments
Laboratory reference / normal range / Insert number / Insert comment
Certification/accreditation of local laboratory / Insert number / Insert comment
Record of retained body fluids / tissue samples / Insert number / Insert comment

Patient Information,

Informed Consent & CRF

Yes /

Box #

/ No / NA / Comments
Sample patient information sheet / Insert number / Insert comment
(including all translations)
Sample informed consent / Insert number / Insert comment
(including all translations)
Sample case report forms / Insert number / Insert comment

Original Informed Consent

Subject ID

Subject Initial

/ Yes /

Box #

/ No / NA / Comments
<Insert ID number> / <Insert initial> / Insert number / Insert comment
<Insert ID number> / <Insert initial> / Insert number / Insert comment
<Insert ID number> / <Insert initial> / Insert number / Insert comment

Investigator’s Brochure

Investigational Product

Yes /

Box #

/ No / NA / Comments
Investigator’s brochure and updates / Insert number / Insert comment
Investigational product insurance / Insert number / Insert comment
IP shipping records / Insert number / Insert comment
Sample of IP label / Insert number / Insert comment
Documentation of destruction of unused IP / Insert number / Insert comment
(if destroyed at site)

Study Records and Log

(completed, signed and dated)
Yes /

Box #

/ No / NA / Comments
Advertisement for subject recruitment / Insert number / Insert comment
Subject Screening Checklist / Insert number / Insert comment
Subject Study Visit Schedule / Insert number / Insert comment
Subject Screening Log / Insert number / Insert comment
Subject Identification List / Insert number / Insert comment
Subject Enrolment Log / Insert number / Insert comment
IP Accountability Log / Insert number / Insert comment
IP Dispensing Log / Insert number / Insert comment
Specimen Dispatch Log / Insert number / Insert comment

Serious Adverse Event

Yes /

Box #

/ No / NA / Comments
SAE report / Insert number / Insert comment
SAE notification letters / Insert number / Insert comment
Sponsor’s safety update / Insert number / Insert comment

Source Documents

Yes /

Box #

/ No / NA / Comments
Medical records / clinical progress notes / Insert number / Insert comment
Laboratory report / Insert number / Insert comment
Laboratory requisitions forms / Insert number / Insert comment
Subjects diary / Insert number / Insert comment
Instrument print-outs / Insert number / Insert comment
Chest x-rays / Insert number / Insert comment
Official clinical diagnostic procedure results / Insert number / Insert comment
Autopsy reports, death certificates / Insert number / Insert comment
Patient-specific correspondence e.g. email messages, faxes, documented phone calls / Insert number / Insert comment

NCR paper CRF

Subject ID

/ Subject Initial / Yes /

Box #

Paper DCF (copy)

Subject ID

/ Subject Initial / Yes /

Box #

Randomisation

Yes /

Box #

/ No / NA / Comments
Sealed envelope of treatment code / Insert number / Insert number
Emergency unblinding procedures (if not in protocol) / Insert number / Insert comment
Decoding envelopes / Insert number / Insert comment

Correspondence

Yes /

Box #

/ No / NA / Comments
Contact notes, letter, fax, e-mail & telephone contact report with CRC/sponsor and all sites / Insert number / Insert number
Sponsor / CRA visit log / Insert number / Insert number
Pre-study visit reports / Insert number / Insert number
Study initiation site visit reports / Insert number / Insert number
Study close-out reports / Insert number / Insert number
SOP documents / Insert number / Insert number
Inventory of study supplies form / Insert number / Insert number
Acknowledgement of receipt / Insert number / Insert number
Delivery order of IP / Insert number / Insert number
Mails of investigator’s meeting / Insert number / Insert number
Minutes of investigator’s meeting / Insert number / Insert number

Others documents (please specify)

Yes /

Box #

/ No / NA / Comments
Insert document title> / Insert number / Insert number
Insert document title> / Insert number / Insert number
Insert document title> / Insert number / Insert number
Reviewed by: / <Insert name> / Approved by: / <Insert name>
Signature: / <Insert signature / Signature: / <Insert signature
Date: / dd/mm/yyyy / Date: / dd/mm/yyyy