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Policies & Sops

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download a document from this site it becomes uncontrolled and so you must always check before use that it has not been superseded.


Version & Date

Associated Forms & Templates

Training Record


Policies SOPs and GCP Researcher Training Record

V3.0 17 December 2019

  •  N/A


Income Distribution from Commercial Research Activity V5.0 August 2017

V5.0 Aug 2017

  •  N/A

PHT/RDPOLICY/002 - Clinical Research Safety Monitoring Policy

V2.0 07 Apr 2016

  •  N/A

 Research Communications Policy


V1.0  01 May 2017

  • N/A



PHT/RDSOP/001 - SOP for the Development, Management & Control of Research-related SOPS

V1.1 07 April 2016


PHT/RDSOP/002 - SOP for Reporting and Managing Non Compliance and Serious Breaches in Clinical Research

V3.0 09 Sept 2019

PHT/RDSOP/003 - SOP for Monitoring Research Studies Sponsored by PHT

 V2.0 16 Dec 2019


PHT/RDSOP/005 - SOP for Recruiting & Consenting Patients into Clinical Research 

V2.0 14 November 2017

PHT/RDSOP/006 - SOP for Reporting Urgent Safety Measures in Clinical Research

V2.0 16 December 2019

PHT/RDSOP/007 - SOP for Investigators: Recording, Assessing & Reporting Adverse Events in Clinical Research

V2.0 07 April 2016

PHT/RDSOP/009 - SOP for Establishing and Maintaining a TMF or ISF

V2.0, 09 Sept 2019

PHT/RDSOP/011 - Preparation and Procedure to Archive

V1.2, 12 Nov 2018


PHT/RDSOP/012 - Delegation of Roles & Responsibilities

V1.1 07 April 2016

PHT/RDSOP/013 - SOP for Data Management

 V1.0 26th April 2016

  • N/A

PHT/RDSOP/014 - SOP for Randomisation and Blinding 

 V1.0 26th April 2016

  • N/A

PHT/RDSOP/015 - SOP for Protocol Development 

 V1.0 26th April 2016

PHT/RDSOP/016 - SOP for Management of Amendments to PHT Sponsored Studies 

 V2.0 5th October 2018

  • N/A

PHT/RDSOP/017 - Creation of Crib Sheets for Clinical Data Collection

 V1.0 05 August 2016

  • N/A


PHT/RDSOP/018 - SOP for Risk Assessment of Studies Sponsored by PHT

 V1.0 16 December 2019

PHT/RDSOP/019 - SOP - Developing a Monitoring Plan for Studies Sponsored by PHT

 V1.0 16 December 2019

PHT/RDSOP/020 - SOP for Initiating and managing CAPA plans

 V1.0 16 December 2019

Work Instructions

PHT/WI/39 - Reporting Research Incidents on Datix

 v1.0 23 August 2016

  • N/A


Related content

Last updated - 17 December 2019
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