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Templates

Please remember that whenever you download a document from this site, it becomes immediately uncontrolled so you must always check before use that it has not been superseded.

Document Name

Version & Date

Purpose

Document Download

Trial Master File (TMF) & Investigator Site File (ISF)

TMF / ISF Filing Index

Single site sponsored  studies only

V3.0 Feb 2012

To be used in the set up of a Trial Master File (TMF). For single site studies, sponsored by PHT. A contents page is also provided.

Click Here

TMF Study Level Filing Index

Multi-site sponsored studies only

V3.0 Jan 2012

To be used in the set up of a TMF for Multi-site studies sponsored by PHT. * Concerned with information that is at a central/study level and to be kept by the Chief Investigator. A contents page is also provided.

Click Here

TMF Site Level Filing Index

Multi-site sponsored studies only

V3.0 Jan 2012

To be used in the set up of a TMF for Multi-site studies sponsored by PHT. * Concerned with site level information and to be kept by the Chief Investigator for each site. A contents page is also provided.

Click Here

Investigator Site File (ISF) Filing Index

Single site hosted and multi-site sponsored studies

V3.0 31 Jan 2012

To be used in the set up of an Investigator Site File (ISF) for PHT hosted studies.* Also to be used by external sites participating in a multi-site study sponsored by PHT. A contents page is also provided.

Click Here

Study Summary & Contacts Page

V1.0 12 Apr 2011

To record study summary and contact details in the TMF/ISF.

Click Here

File Note Template

V1.0 16 Sep 2011

To document any notes to file, for e.g. issues of note, statements, follow-up actions, missing information or documentation, communications.

Click Here

TMF Location Form

V1.0 29 Sep 2011

To record and notify the Research Dept of the location of a TMF.

Click Here

ISF Location Form

V1.0 14 Jul 2011

To record and notify the Research Dept of the location of a ISF.

Click Here

TMF/ISF Location Tracker Sheet

V1.0 08 Nov 2012

To track the location of the TMF/ISF so that it can be found at all times. To be used whenever the TMF/ISF is moved from its specified location (see location forms above).

Click Here

Sponsor Delegated Roles and Responsibilities Matrix

V1.0 03 Sep 2014

 

To be used when PHT is the Sponsor and may delegate responsibilities to the:
• The Chief Investigator
• The Principal investigator (when multisite)
• The research fellow leading the study
• Subcontractor (for e.g a CTU)
• Collaborator

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Template Logs

Version Control Log

V1.1 21 Jul 2011

To record current and superseded key essential documents. Includes versions, dates and approval dates. To be kept in the TMF/ISF.

Click Here

Study Delegation and Signature Log

V4.0 Feb 2012

To record roles, responsibilities, delegated tasks and signatures during a study.

Click Here

Study Screening & Enrolment Log

V1.2 15 Mar 2012

To record all screening and recruitment activity during a study.

Click Here

Study Training Log

V1.0 04 Apr 2012

To keep a formal record of training received by the Research Team in relation to the study Protocol.

Click Here

Adverse Event Reporting

Adverse Event Form 1

V2.0 08 Nov 2012

To record and assess Adverse Events during PHT Sponsored studies*.

Click Here

SAE Initial Reporting Form 2

V2.0 08 Nov 2012

To make an initial and immediate report of an SAE/SSAR or SUSAR to PHT research office. For PHT Sponsored studies *.

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SAE Follow up Form 3

V2.0 08 Nov 2012

To make a follow up report of an SAE/SSAR or SUSAR to the PHT Research office. For PHT Sponsored studies*.

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SAE Sponsor Assessment Form 4

 V1.0 Oct 2010

To record an independent assessment of a reported SAE/SSAR or SUSAR on behalf of PHT for Sponsored studies.

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Urgent Safety Measures Assessment, Record & Reporting Form

V1.0 04 May 2012

To be completed where an Urgent Safety Measure is required or has been implemented in a study sponsored by Portsmouth Hospitals NHS Trust

 

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Breaches

Study Breach Record and Reporting Form

V1.1 01 May 2012

To record and assess all breaches and report all those identified as serious.

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Amendments

Substantial amendment forms

(Visit links to the right for latest versions)

To apply to the National Research Ethics Service (NRES) and the Medicines and Healthcare products Regulatory Agency (MHRA) for a substantial amendment.

NRES

MHRA

CV

CV Template

V2.0 Jan 2007

To provide summary CV information for members of the research team.

Click Here

Consent

Delegation of Consent Form

V1.0 08 May 2012

To be completed by the Principal/Chief Investigator to assess the suitabilty of a researcher to consent patients to the study.

Click Here

Peer Review

Design Review Form

V2.0 20 Jan 2011

To provide independent peer review of study design and methodology.

Click Here

Topic Area Review Form

V2.0 20 Jan 2011

To provide independent peer review of study topic area, including strategic relevance and need.

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GCP Compliance

 

GCP Compliance Tool

V1.0 13 Nov 2014

To aid a review of your site files, to ensure they are compliant with Good Clinical Practice guidelines.

Click Here

Initiation & Monitoring

Site Initiation Checklist (Sponsored)

Coming Soon

To provide a checklist of documents and actions to be completed before study initiation can take place. For PHT Sponsored studies.

 

Site Initiation Checklist (Hosted)

Coming Soon

To provide a checklist of documents and actions to be completed before study initiation can take place. For PHT Hosted studies.

 

Level 1 Study Monitoring Report Form (Sponsored)

V1.0 13 Feb 2012

For R&D staff use only, to provide a checklist against which the TMF or ISF for a PHT sponsored study can be monitored.

Click Here

Level 2 Study Monitoring Report Form (Sponsored)

V1.1 01 Mar 2012

For R&D staff use only, to provide a checklist against which source documentation, SAEs and other records for a PHT sponsored study can be monitored.

Click Here

Level 1 Study Audit Report Form (Hosted)

V1.0 13 Feb 2012

For R&D staff use only, to provide a checklist against which the TMF or ISF for a PHT hosted study can be audited.

Click Here

Level 2 Study Audit Report Form (Hosted)

V1.1 01 Mar 2012

For R&D staff use only, to provide a checklist against which source documentation, SAEs and other records for a PHT hosted study can be audited.

Click Here

Monitoring and Audit Visit Log

V1.0 16 Feb 2012

To record all monitoring and audit visits that take place throughout the conduct of a study in accordance with the agreed monitoring/audit plan.

Click Here

Stickers, Labels & Inserts

Guidance on the Use of Research Stickers

V1.1 20 Mar 2012

To provide guidance on the purpose and use of all PHT research office issued stickers and labels.

Click Here

SAE Alert Notice

V1.0 08 Nov 2012

An SAE Alert notice is a simple template document used to flag that the patient is in a clinical study that is subject to SAE reporting. The template defines what an SAE is and provides contact details for reporting SAEs to local teams. To be added to the inside cover of all versions of the medical notes.

Click Here

SOP Template

SOP Template

V1.0 Apr 2012

To provide a template for the generation of research related SOPS.

Click Here

Archiving

      

Archiving Contents Form

V1.1 31 Oct 2014

To record the contents of a box when it is sent to the off site archiving facility for storage or archiving.

 

Click Here

 

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Contact

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Cosham, Portsmouth
PO6 3LY
Tel: 023 9228 6000

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