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STANDARD OPERATING PROCEDURE FOR THE PREPARING AND MAINTAINING A

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					ACCORD                                                     SOP number: ACCORD/SOP13/2.0
NHS Lothian R&D and                                                               Version 2.0
The University of Edinburgh                                       Effective Date: 30/06/2009




    STANDARD OPERATING PROCEDURE FOR ARCHIVING
              CLINICAL RESEARCH DATA

SOP NUMBER:                   ACCORD/SOP13/2.0

VERSION NUMBER:               2.0

PREVIOUS VERSIONS:            1.0

EFFECTIVE DATE:               30/06/2009

REVIEW DATE:                  31/05/2011

AUTHOR:                       Fiona Sloan (Clinical Trials Monitor)


AUTHOR:                       .....Fiona.Sloan.....................................
                                (ACCORD Clinical Trials Monitor, NHS Lothian)

DATE:                               11/06/2009


APPROVED BY (1):              .....Tina.McLelland...................................
                                 (R&D Governance Manager, NHS Lothian)

DATE APPROVED:                      23/06/2009


APPROVED BY (2):              .....Marise.Bucukoglu................................
                                    (Research Governance Manager)


DATE APPROVED:                      11/06/2009


RELEASED BY:                  .....Dawn.Lyster........................................
                                    (QA Group, University of Edinburgh)



DATE RELEASED:                      11/06/2009




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ACCORD                                                 SOP number: ACCORD/SOP13/2.0
NHS Lothian R&D and                                                           Version 2.0
The University of Edinburgh                                   Effective Date: 30/06/2009


1. PURPOSE

To describe the procedure for archiving research documentation for research studies
sponsored by NHS Lothian and/or the University of Edinburgh.


2. APPLICABILITY

Applies to Chief Investigators (CI) running clinical research studies sponsored by
NHS Lothian and/or the University of Edinburgh. Applies to all members of ACCORD
who manage, coordinate or advise on clinical research sponsored by NHS Lothian
and/or the University of Edinburgh.

Applies to both Clinical Trials of Investigational Medicinal Products (CTIMPs) and
research studies other than CTIMPs (non-CTIMPs).


3. POLICY

For CTIMPs that are within the scope of the Medicines for Human Use (Clinical
Trials) Regulations 2004, the sponsor has responsibility for archiving the trial
documentation. For CTIMPs that are sponsored by the NHS Lothian and/or the
University of Edinburgh the responsibility for archiving may be delegated to the Chief
Investigator (CI). Such delegation of responsibility should be agreed at the beginning
of the trial and should be clearly documented in the sponsorship/site agreements.

For external sites taking part in a multi-centre study that is sponsored by NHS
Lothian and/or the University of Edinburgh the Principal Investigator (PI) for that site
is responsible for archiving research documentation locally. The PI should confirm in
writing to the sponsor that the research study documentation will be archived for the
required period of time.

In instances where the responsibility for archiving remains with NHS Lothian and/or
the University of Edinburgh as sponsor, archiving may be arranged through the NHS
Lothian R&D Department. NHS Lothian R&D will have a nominated individual who
has overall responsibility for archiving within the unit.

The relevant documentation from CTIMPs will be archived for at least five years after
the conclusion of the trial as required by the Medicines for Human Use (Clinical
Trials) Regulations 2004, unless the funding body stipulates longer. The relevant
documentation from non-CTIMPs will be archived for at least five years after the
conclusion of the study unless the funding body stipulates otherwise.


4. PROCEDURE

4.1     ARRANGEMENTS FOR ARCHIVING

4.1.1   Appropriate arrangements for archiving research documentation should be in
        place before the research starts, for example, identifying the likely method of
        archiving, identifying a suitable location for archiving documents.
4.1.2   If off-site archiving will be required, the likely cost of this should be factored
        into the research funding.

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                          Controlled Document – Do Not Copy
ACCORD                                                 SOP number: ACCORD/SOP13/2.0
NHS Lothian R&D and                                                           Version 2.0
The University of Edinburgh                                   Effective Date: 30/06/2009


4.1.3   Some source data, such as electronic records, x-rays, video clips, will require
        storage in particular conditions to ensure that the data does not degrade.
        Such special archiving arrangements should be planned in advance of the
        start of the study.
4.1.4   For non-CTIMPs it is the responsibility of the CI to clarify the requirements for
        archiving with the funding body.

4.2     DOCUMENTS TO BE ARCHIVED

4.2.1   All documents contained in the Trial Master File (TMF) and Investigator Site
        File (ISF) should be archived. Refer to ACCORD SOP/02 (SOP for
        establishing and maintaining a TMF) and ACCORD SOP/06 (SOP for
        establishing and maintaining an ISF) for further guidance.
4.2.2   Source data, such as patient medical notes and x-rays, must also be
        archived. It is the responsibility of the CI to clarify local trust policies on
        retention of medical records to ensure that these source documents are
        retained for at least five years after completion of the study.
4.2.3   The source data and the TMF and ISF should be archived together and
        should be clearly labelled with details of the research study and the date of
        archive.
4.2.4   Any essential trial documentation that was kept somewhere other then the
        TMF or the ISF during the study should be returned to the CI after the study is
        finished so that all documents can be archived together.
4.2.5   Some support departments involved in the study will keep their own records
        that they may also be required to archive in line with departmental policy
        and/or SOPs. In these instances the original document must be returned to
        the CI and a copy may be archived within the department.
4.2.6   All archived documentation should be complete, legible and readily available
        to the regulatory authorities on request.

4.3     OFF-SITE ARCHIVING

4.3.1   For research studies that have a large amount of documentation it may be
        necessary to archive documents off-site using an external company.
4.3.2   If off-site archiving is required, the CI should contact the NHS Lothian R&D
        office for assistance in arranging for an external company to collect
        documents to be archived.
4.3.3   A log of the documents archived off-site, date archived and location of the
        archive should be retained by the CI or the individual with responsibility for
        archiving within NHS Lothian R&D if responsibility for archiving has not been
        delegated to the CI.

4.4 ACCESS TO ARCHIVED DOCUMENTS

4.4.1   Access to archived documents should be restricted to the CI or the individual
        with responsibility for archiving within NHS Lothian R&D if the responsibility
        for archiving has not been delegated to the CI.




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                          Controlled Document – Do Not Copy
ACCORD                                              SOP number: ACCORD/SOP13/2.0
NHS Lothian R&D and                                                        Version 2.0
The University of Edinburgh                                Effective Date: 30/06/2009


5. RELEVANT DOCUMENTS

1. ACCORD SOP/02 “SOP for establishing and maintaining a TMF”
2. ACCORD SOP/06 “SOP for establishing and maintaining an ISF”


6. DEFINITIONS

ACCORD         Academic and Clinical Central Office for Research and Development.
               The ACCORD office is a collaboration between NHS Lothian and The
               University of Edinburgh to form a joint research and development
               office to facilitate clinical research.

ICH-GCP        International Conference on Harmonisation - Good Clinical Practice


7. REFERENCES

Medicines for Human Use (Clinical Trials) Regulations 2004. It is assumed that by
referencing the principle regulations, all subsequent amendments made to the
principle regulations are included in this citation.

ICH Harmonised Tripartite Guideline for Good Clinical Practice, CPMP/ICH/135/95

SCRN SOP number: END OF STUDY 300 (version 2, 13/01/06) ”Archiving”.



DOCUMENT HISTORY

Version      Edited by (job title):   Effective     Details of editions made:
Number:                               Date:
2.0          Dawn Lyster              30/06/2009    Removal of ECTU reference.
             (QA Assistant)                         Amendment to section 4.4.
1.0          Fiona Sloan (Clinical 22/02/2007       Original
             Trials Monitor)




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Description: STANDARD OPERATING PROCEDURE FOR THE PREPARING AND MAINTAINING A