Investigator Site File Index

Trial Information

Study Title: / BioResource for Rare Diseases
Chief Investigator: / Prof VKK Chatterjee
REC Number: / 04/Q0108/44
Site R&D Reference:
Section / Documents /
0.0 / Index, File Note & Document Control Logs
1.0 / Protocols & Selected Exome-sequencing projects for Site
1.1
1.2
1.21
1.22
1.23
1.24
1.25
1.26
1.3
1.31
1.32
1.33
1.34
1.35
1.36
1.4
1.41
1.42
1.43
1.44
1.45
1.46
1.5
1.51
1.52
1.53
1.54
1.55
1.56 / BioResource Protocol (current & superseded versions)
BPD (Bleeding & Platelet Disorders)
Summary/Inclusion & Exclusion of BPD project
Key Contacts
BPD Site Delegation Log (inc. CV/GCPs)
BPD Sample CRF
Completed consent forms for site
Subject ID Log
PAH (Pulmonary Artery Hypertension)
Summary/Inclusion & Exclusion of PAH project
Key Contacts
PAH Site Delegation Log (inc. CV/GCPs)
PAH Sample CRF
Completed consent forms for site
Subject ID Log
PID (Primary Immune Deficiency)
Summary/Inclusion & Exclusion of PID project
Key Contacts
PID Site Delegation Log (inc. CV/GCPs)
PID Sample CRF
Completed consent forms for site
Subject ID Log
SPEED (Specialist Pathology Evaluating Exomes in Diagnostics)
Summary/Inclusion & Exclusion of SPEED project
Key Contacts
SPEED Site Delegation Log (inc. CV/GCPs)
SPEED Sample CRF
Completed consent forms for site
Subject ID Log
2.0 / Participant Documentation
2.1
2.2
2.3 / Participation Information Sheets
Informed Consent Forms
Clinician letter templates
3.0 / Research Ethics Committee
3.1
3.2
3.3
3.4
3.5 / Original Bioresource ethical approval
File Note: Bioresource Ethics (with link to amendment submissions/approvals)
Amendment 15: Bioresource for Rare Diseases
Post amendment 15: Amendments & approvals
REC correspondence
4.0 / R&D
4.1
4.2
4.3
4.4 / Local R&D approval including SSI
Amendment(s) notifications to site R&D with approvals
Annual Report correspondence
Other R&D correspondence
5.0 / Sponsor & Finance
5.1
5.2
5.3
5.4
5.5
5.6
5.7 / Insurance and/or Indemnity Statement (file note relevant for NHS Indemnity)
Sponsorship agreement/letter
Non-commercial agreement
Contract / Contract Addendums with sub-contractors / third parties
Participating Site Log (including Sample Transfer agreement or log)
Invoices/Record of study payments
Annual Report related correspondence with Sponsor
6.0 / Reporting
6.1
6.2
6.3 / Trial Reporting Guidelines
SAE Reporting Form template
Completed SAE Forms / Listings (clinical evaluation forms) and associated correspondence
7.0 / Clinical Laboratory
7.1
7.2
7.3
7.4 / Laboratory Manual for site
Sample shipment Log
Storage condition monitoring (e.g. fridge/freezer temps)
Tracking of reportable events
8.0 / Statistics & Data Management
8.1 / Data Management Plan
8.2 / Database Management Documentation
8.3 / Statistical Analysis Plan
8.4 / Data Management & Statistical Correspondence
9.0 / Study Management and Monitoring
9.1 / Trial Management Meeting documentation
9.2 / Trial Steering Committee
9.3 / Data Monitoring Committees
9.4 / Study risk assessment
Monitoring Arrangement
Study Initiation Meeting documentation
Monitoring Correspondence
9.5
9.6
9.7
10.0 / Quality Assurance & Audit
10.1
10.2 / Index of SOPs
Study-specific SOPs
10.3 / Audit certificates
10.4 / Audit correspondence
11.0 / End of Study Reports / Publications
11.1
11.2 / End of study report
End of study notifications to R&D, Ethics & Sponsor
11.3 / Publications


General Guidance

-  Superseded versions can be marked by a single line through the front page, noting “Superseded”, initialled and dated;

-  Some sections can be sub-divided to ease filing;

-  Correspondence and version-controlled documents must be filed in chronological order with the most recent on top;

-  Completed participants’ CRFs are considered part of the TMF/ISF but must be filed separately.

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