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					                          British Paediatric Surveillance Unit

                         System Level Security Policy (SLSP)

                                      [Study Name]


Instructions for completion
    This is a sample template to assist you in drafting an SLSP for your PIAG
      submission
    The text and diagrams are samples and are not intended to reflect with 100%
      accuracy the data flows, data processing and security measures specific to your
      study
    It is the responsibility of each principal investigator (PI) to decide on the content
      and structure of their SLSP and edit this sample template appropriately (if you
      wish to use it) so that it reflects data flows, data processing and security measures
      specific to their study
    PIs are under no obligation to use this SLSP template.
          o PIAG have a sample template which can be used which is available at
              http://www.advisorybodies.doh.gov.uk/piag/securitypolicytemplate.rtf
          o The PI’s lead organisations may have their own SLSP
          o PIs can develop their own SLSP




                              Version 8th September 2005                                      1
[Sample] Background

The [study name] complies with BPSU policy on data handling and data storage.

   BPSU office receives an ‘orange card’ indicating that a case of [condition] has been
    seen by a clinician
   BPSU office informs [study applicants] that a case of [condition] has been seen by a
    clinician
   [Study applicants] send questionnaire to relevant clinician for completion
   [Study applicants] detach front sheet of questionnaire (containing patient identifiable
    information) from the clinical data sheets of the questionnaire (containing research
    data)
   The front sheet and the clinical data sheets have a code assigned to the case it
    represents (BPSU Case code)
   Front sheet and clinical data sheets are stored separately in secure locked cabinets and
    accessed only by nominated [study applicants]
   Clinical data sheets contain research data only – they are linked to the corresponding
    front sheet (which contains patient identifiable information essential only for the
    identification of duplicates and case verification) by means of the unique BPSU Case
    Code
   Patient identifiable information essential only for the identification of duplicates and
    cases verification is destroyed once the process of case verification and de-
    duplication has been completed.
   Only the research data held on the clinical information sheets is entered onto a
    computer

[Sample] Appendix 1 summarises the data handling and data storage processes in the
system.


The System Level Security Policy (SLSP) for [study name] has been developed through a
formal process of risk assessment by the [study applicants]. It covers security and
management procedures in place throughout for data collection, data handling, data
storage, data analysis and data destruction. It details the lines of accountability within the
[lead organisation] and where relevant [other bodies] who may legitimately use it. It
references external security documentation and standards, including the [lead
organisation’s] corporate security policy and where relevant the security policies and
procedures of [other organisations.]




                               Version 8th September 2005                                        2
System Level Security Policy

1. Name of system: [study name]

2. Responsible Owner: [Lead Investigator]

3. System’s Caldicott Guardian or Data Controller:[Name of your Caldicott
   Guardian]

4. Overview of Security System:

    Security of the system shall be governed by the corporate security policy of [lead
    organisation] [Ref]

    The system’s responsible security manager is [Caldicott Guardian should be able to
    provide this name]. He/She is the individual responsible for:

    Sample list
     Accrediting the system’s security implementation
     Maintenance of the IT network including firewall and virus protection
     Security sign-off/accreditation
     Staff security and training

5. System Structure

    5.1 Overview
    The system was developed by [study applicants] and will be implemented by the
    BPSU, [study applicants] and [named administrators]1. In accordance with Medical
    Research Council (MRC) guidance, paper records i.e. front and clinical data sheets
    will be held for a total of 20 years 2 to allow adequate time for review or reappraisal
    and to allow any concerns about the conduct or consequences of the study to be
    resolved. Paper records will then be permanently destroyed by shredding.

    The exception to retention of paper records is patient identifiable information
    collected for the purposes of case verification and de-duplication. This is destroyed
    once this process has been completed (Usually within 12 months).


    5.2 System Components

    The System comprises:
    1. Desktop computer holding electronic research data (clinical data sheets of
       questionnaire)
    2. Paper records consisting of the front and clinical data sheets of the questionnaire.
       a. Front and clinical data sheets are stored separately in locked cabinets with
          restricted access and linked only by a unique BPSU case code
1
  Those involved in the implementation of the study may change for a variety of reasons e.g. staff turnover,
new researchers etc.
2
  Medical Research Council. Personal Information in Medical Research. Available at
http://www.mrc.ac.uk/pdf-pimr.pdf


                                    Version 8th September 2005                                                 3
       5.3 System Processes

       The system will process:
       1. Patient identifiers consisting of [list]. Patient identifiable information collected for
          the purposes of case verification and de-duplication only are destroyed once this
          process has been completed.
       2. Electronic research data (clinical data sheets of questionnaire) which is the only
          data entered onto computer
       3. Paper records consisting of the front and clinical data sheets of the questionnaire
          are stored separately in two locked cabinets and linked only by a unique BPSU
          case code

       Anonymised notifications are provided to the BPSU office by members of the
       RCPCH using BPSU methodology i.e. the orange card. The BPSU informs the lead
       investigator or their nominated staff of the notifying member's details so the
       investigators can request further details. Members notifying cases subsequently
       submit patient data to the investigator. Patient data are not held by the BPSU.

       5.4 System Authorised Purpose

       [List study aims and objectives]

       5.5 System Authorised Users

       BPSU, [study applicants] and [named administrators] 3.

       5.6 System Network

       The system is [standalone] or [networked] to the [lead organisations] network.


       5.7 System security

       The system has the following security measures in place: [Address the physical
       location, access control, privileges, network protection etc. Please note that NHS
       organisations are required to comply/work towards compliance with security
       management practices as set out in BS7799/ISO 17799.]

       Sample list
       1. Firewall
       2. Virus protection
       3. Password protected
       4. Locked rooms/cabinets
       5. CCTV protected office




3
    Authorised users may change for a variety of reasons e.g. staff turnover, new researchers etc.


                                      Version 8th September 2005                                     4
     5.8 Risk assessment and audit arrangements

     The system shall be risk assessed on an annual basis by the [lead investigator] using
     an audit checklist. Changes in personnel, any deficiencies, including security or
     confidentiality matters, will be identified and discussed with the [system Caldicott
     Guardian] and [system security manager] and solutions implemented.


6. System Recovery Mechanisms

The system has the following resilience arrangements in place:

     1. Electronic research data is backed up daily on the network
     2. A copy of research data that has been entered is held securely off site
     3. Paper records consisting of the front and clinical data sheets of the questionnaire
        are stored separately in two locked cabinets with restricted access and linked only
        by a unique BPSU case code

In the event of an electronic system failure the database system can be retrieved from our
off site facility and can be re-loaded in an appropriately secure system

7. Data Destruction

When the study is complete the following methods will be adopted to dispose of all
stored data

     1. Patient identifiable information, essential only for the process of de-duplication
        and case verification will be permanently destroyed once this process has been
        completed.
     2. Data entered on computer will be permanently wiped from the hard drive


8.   Responsibility for [Name of study] SLSP

This SLSP is the responsibility of [Lead investigator] and shall be reviewed on an annual
basis as part of the risk assessment and audit processes in place.

This SLSP has been made available to the [Lead organisation Caldicott Guardian],
[System IT security Manager] and BPSU




                               Version 8th September 2005                                     5
               [Sample] Appendix 1     Data handling and storage in [Name of Study]

                                                                      Front sheet containing
                                                                      patient identifiable
                                                                      information is separated
                                                                      from clinical data sheets
       Front sheet
Patient identifiable
information collected for
the purposes of case
verification and de-                                                              Clinical Data Sheets
duplication are
immediately destroyed                                                            Clinical data sheets
once this process has                                                            contain research data
been completed.                                                                  only




                                       Front Sheet & Clinical
                                       Data sheets are linked by a
                                       unique BPSU Case Code




                                                                                     Clinical data sheets
                                                                                 Stored in locked cabinets
         Front sheet
                                                                                 with restricted access.
Stored in locked cabinets
with restricted access.


                                       Clinical Data Sheets
                                       Only research data
                                       from clinical data
                                       sheets are entered onto
                                       computer.




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