OCTRU TEMPLATE: OT-026
Trial Documentation Checklist
(This Template related to OCTRU SOP: GEN-017)
Note: This document is not a replacement for the Investigator Site File (ISF) contents, but is used as a tracking tool for CTU
documents which are likely to be updated throughout the life of the trial and which are usually sent to the sites.
Note: This document is to be completed by the Trial Management (TM) Team and sent to the site as part of the set-up and
maintenance of the ISF. This document must be kept up to date as and when Documents (Table 1) and Templates (Table 2) are
updated and superseded (Table 3).
The versions sent to the site are only the ones active at the time of set-up and activation for the site in question, and updates
thereafter. Sites are not required to have previous versions from before the date of activation for that site.
Table 1: Current Documents
Document
Current Version and Date
Protocol
V2.0 18Aug2016
PIS
Consent Form
Physiotherapy Advice Sheet
GP letter
V2.0 18Aug2016
V2.0 18Aug2016
V2.0 18Aug2016
V2.0 18Aug2016
Questionnaire Cover Letter
N/A- this document is not sent to sites but is used internally by trial
office
Ethics Approvals
 Original Approval - 18 Mar 2016
 Acknowledgement of Am 001 (Non-substantial) - 03 May 2016
 Approval of Am 002 (Substantial) – 16 Sep 2016
Form 1: Randomisation Form
Form 2: Pt Contacts
V1.0 17 Jun 2016
V1.0 17 Jun 2016
Baseline Pack
V1.0 17 Jun 2016
8 Week Pack
V2.0 24 Oct 2016
Form 5: DVT/PE
Form 6: SAE Reporting Form
Form 7: Protocol Deviation
Form 8: Withdrawal/Death
V1.0 17 Jun 2016
V1.0 17 Jun 2016
V1.0 17 Jun 2016
V1.0 17 Jun 2016
Questionnaires
All questionnaires to be used by site incorporated into baseline and
8 week pack. The 3, 6 and 9 month questionnaires are posted
direct to patients by Oxford University trial unit staff.
ISF1 Contents List
ISF2 – Working file – Contents List
CTU contact details (ISF1 Section 1.1)
Trial Summary (ISF1 Section 1.3)
Guidance Sheet: Randomisation (ISF1 Section 2.1)
V2.0 15Aug2016
V2.0 15Aug2016
V2.0 28Sep2016
V1.0 05Jul2016
V1.0 03Jun2016
__________________________
UKSTAR
V7.0 12Dec2016
OCTRU-OT-026_V1.0_15May2015
Effective Date 15May2015
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OCTRU TEMPLATE: OT-026
Trial Documentation Checklist
(This Template related to OCTRU SOP: GEN-017)
Guidance Sheet: CRF Completion (ISF section 7.1)
CRF schedule (ISF Section 7.2)
Guidance Sheet: SAE Reporting (ISF Section 8.1)
Training Log (ISF1 Section 15.2)
V3.0 09Dec2016
V2.0 04Aug2016
V1.0 12Jul2016
V1.0 12Jul2016
Table 2: Current Templates/Forms
Template/Form
Version and Date
Staff Contact &
Responsibilities Sheet (SCRS) (ISF1 Section 4.1)
V4.0 28Oct2016
Delegation Log
Not used in this trial- each staff member should just
complete one SCRS sheet (see above) each
Participant Screening Log (ISF1 Section 2.2)
V2.0 30Nov2016
Participant Identification Log (ISF1 Section 2.3)
V1.0 26May2016
Randomisation Procedures & Dates- can be used by sites if they
find helpful (ISF1 Section 2.5)
V1.0 05Jul2016
Table 3 : History of Protocol Versions & Associated Documents & Approvals
Please complete a new row every time there is an amendment in one or more of the documents. If one or more of the documents
has not changed, copy the same version number and date for that document from the previous row.
Main REC
Approval/
Acknowledged
Protocol
PIS
07 Apr 2016
V1.0
27Jan2016
V1.1
04Apr2016
03 May 2016
(AM001- NSA)
V1.1
06Apr2016
V1.2
06Apr2016
Consent
Form(s)
GP Letter
V1.0
13Jan2016
V1.0
13Jan2016
NO CHANGE
V1.0
13Jan2016
V1.0
13Jan2016
NO CHANGE
Physio Advice
Sheet
Questionnaires
V1.0
01Feb2016
ATRS
EQ-5D
V1.1
06Apr2016
NO CHANGE
Baseline V1.0 17Jun2016
8 Wk V1.0 17Jun2016
16 Sep 2016
(AM002 – SA)
V2.0
18Aug2016
V2.0
18Aug2016
V2.0
18Aug2016
V2.0
18Aug2016
V2.0
18Aug2016
(3 month V1.0
17Jun2016- not used by
sites)
(6 month V1.0
17Jun2016- not used by
sites)
(9 month V1.0
17Jun2016- not used by
sites)
__________________________
UKSTAR
V7.0 12Dec2016
OCTRU-OT-026_V1.0_15May2015
Effective Date 15May2015
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