STH Research Department

Research Department

Research Governance

Investigator Site File

This guidance applies to all research registered within STH Trust, regardless of design or location.

The Investigator Site File should contain the essential documents, which individually and collectively permit evaluation of the conduct of a research trial. The contents of the file serve to demonstrate the compliance of the investigator and the research team with the standards of Good Clinical Practice (GCP) and to the requirements of the Research Governance Framework.

The documents contained in the site file are those that will be audited as part of the research governance process to confirm the validity of the trial conduct.

*Some sub-sections may not apply to all projects. If you are unsure about whether a particular element applies to your project, please seek advice from Research Department. All other sections apply to all projects.

Research Department

Sheffield Teaching Hospitals NHS Foundation Trust

305 Western Bank

Sheffield S10 2TJ

0114 271 3740/3916

June 2007

Investigator Site File

Principal Investigator:
Sponsor Reference (STH Number):
Protocol Title:
REC Name:
REC Reference No:
Site Specific Assessor
(SSA):
SSA Reference No:

Contents

1 Study Protocol

1.1A copy of the final approved protocol & approved amendments

1.2A copy of the final approved participant information sheet(s)

1.3 A copy of the final approved participant consent form

1.4Adverts for recruitment *

1.5A copy of the study assessment tools (questionnaires, diaries etc) *

1.6Information for GPs or consultants (version and date)*

1.7Letters of invitation to participants (version and date)*

2Independent Scientific Review

2.1 Report of independent reviewers

2.2Evidence of scientific review/ file note ifaccredited

2.3Comments from statistician

3Ethics

3.1The Ethics Committee Approval letter 

3.2Site Specific Assessment*

3.3Amendment Approval*

3.4All correspondence with the committee(s)

4Regulatory Documents*

4.1Eudract Registration (copy) 

4.2MHRA Application form for CTA (copy) 

4.3MHRA CTA

4.4 MHRA Notice of no objection

4.5CE-marked device instructions for use

4.6Investigator brochure/product summary

4.7ARSAC/IRMER certificate

4.8Radiation dose & risk assessment

4.9Section 60 Health and Social Care Act 2001

4.10Home Office Licence for Animal Studies

5Research Governance Documents

5.1 Project registration form: NRES / Non-ethics

5.2NHS R&D form/SSI Form/STH Finance form

5.3Research Department Authorisation Letter

5.4Research Department Amendments Letter

5.5Confirmation of Sponsorship letter/ agreement

5.6Sponsorship allocation of responsibilities

5.7Data ProtectionNotification Form

5.8Health and safety requirements*

5.9Intellectual property rights*

6Financial Management

6.1 ModelContract/financial agreement/side letter*

6.2 Confirmation of funding*

6.3Indemnity arrangements

6.4Certificate of insurance

6.5Trust finance approval: See section 5.2

6.6Financial tracking

7Investigator, facilities and Research Team

7.1Local Principal Investigator CV (signed and dated)

7.2Co-investigators CVs and training record signed and dated 

(including research nurses/co-ordinators, pharmacists, research

associates)

7.3 Signature Log of all members of the research team

7.4List of tasks and responsibilities delegated to co-investigators

7.5 Honorary contract for non-STH staff

8Project Management

8.1 Membership of project steering group/meeting minutes

8.2Standard Operating Procedures for trial specific tests/interviews/

focus groups and the processing of study material/data

8.3 Data management arrangements/security of data storage/

list of personnel authorised to access data, electronic or paper/

8.4 Laboratory Accreditation certificate*

8.5 Normal laboratory values*

8.6Monitoring arrangements form

9Participant Information

9.1Originals of consent forms signed by trial participants and

Investigator or record of people you informed for observational

studies

9.2 Participant recruitment log

9.3Record of retained body fluids/tissue samples*

9.4 Record of tapes and transcripts of interviews and focus groups*

10Pharmacy*

10.1Pharmacy Arrangements

10.2Randomisation/Treatment allocation procedures

10.3Code Break procedures

10.4Prescribing/transcribing arrangements

10.5Dispensing log

10.6Drug Accountability

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STH Research Department

11Data Collection

11.1Blank copy of data collection sheet/interview schedule

12Serious Adverse Events*

12.1SAE Initial and Follow Up Reports

12.2Notification to Sponsor

12.3Notification to Ethics

13Correspondence

13.1All trial related correspondence other than 3.1, 3.4, 5.3 and 5.4

14Study Closure

14.1Recruitment summary

14.2Archiving arrangements

14.3Dissemination: plans for/record of

15Monitoring and Auditing

15.1Plan of study

15.2Record of internal monitoring

15.3Monitoring reports supplied to Research Department,

Ethics Committee, Funding organisation and Sponsor

15.4Final Study Report

15.5Audit Self Declaration Returns

16Research Governance Compliance

16.1Declaration of Helsinki

16.2ICH Good Clinical Practice (GCP) booklet

17Study Related Literature*

18Superseded Documents*

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