Standard Operating Procedure (SOP) for Audit Scope Abbreviations by reuotld5


									                               Clinical Trials Offices
                               (London and Leiden)

          Standard Operating Procedure (SOP) for

The scope of this SOP is to describe the procedure established by the EBMT
to ensure that all trials sponsored by the EBMT are audited in accordance to
the principles of ICH-GCP and of all applicable laws in each participating

The audit plan for a specific study should take into account the importance of
the trail in respect to regulatory submissions, e.g. is it a registration trial, the
type and complexity of the study, the perceived level of risk to the participants
and the number of patients to be enrolled. Consequently although this SOP
sets out minimal standards for the overall conduct of audit, these may be
adjusted to accommodate the needs of specific studies if deemed necessary.

SOP           Standard Operating Procedure
EBMT          European Group for Blood and Marrow Transplantation
ICH-GCP       International Committee for Harmonisation – Good Clinical
PCTC          Prospective Clinical Trials Committee
CTO           Clinical Trials Office

ICH-GCP guidelines state that

 “the Sponsor of a clinical trial is responsible for implementing and
maintaining quality assurance and quality control systems , with written SOPs,
to ensure that trials are conducted and data are generated, documented
(recorded) and reported in compliance with the protocol, GCP and the
applicable regulatory requirement(s).”

As the sponsor of clinical trials the EBMT must have in place and SOP to
describe what is audited, how it is audited, how frequently audits are
conducted and should identify the components of an audit report.

Personnel appointed to act as auditors should be independent of the trial
being audited and should have sufficient experience and/or training in the
conduct of audits.

               Standard Operating Procedure for Audit Version 1: 9th June 2006

                                           1 of 3
                               Clinical Trials Offices
                               (London and Leiden)

Responsible Personnel
Audit, for quality assurance purposes, will be conducted primarily, by the
members of the PCTC and staff from the three Clinical Trials Offices. In
addition members of the EBMT working parties or other experts may be
drafted onto an audit committee as deemed necessary. The audit of any
study will be conducted by personnel not affiliated or involved in the conduct
of that study. The audit of any of the CTOs will be conducted by staff not
based at that CTO.

Audit will be carried out to fulfil two purposes:
  1. Audit of the of the 3 CTOs, London, Leiden and Paris to the ensure that
       all trials coordinated by the CTOs are conducted in accordance with
       ICH-GCP and all applicable laws, on an annual basis.
  2. Audit of randomly selected studies, across five centres on an annual

The CTOs will be notified at least 45days prior to audit
The Centres will be given 3 months notice prior to a proposed audit.
Both may request a change to the proposed date if necessary

CTO Audit

On an annual basis each of the 3 CTOs will be visited by an audit team to
review the following:

      Trial Master Files, specifically to check for all essential documentation
      for up to 3 studies maximum, studies will be randomly selected and the
      centre notified of which studies will be audited prior to the visit.
      Check 100% of SAEs reported on a randomly selected study
      Review the initiation reports for 10% of centres for a randomly selected
      Review CRF tracking in reference to the EBMT SOP on document
      Inspect facilities for storage of all trial related documentation and

Centre Audit

On an annual basis, 5 institutions, participating in EBMT sponsored studies
will be randomly selected for an audit. At each institution one study will be
randomly selected. The following will be reviewed:

               Standard Operating Procedure for Audit Version 1: 9th June 2006

                                           2 of 3
                                Clinical Trials Offices
                                (London and Leiden)
       Trial Site File, specifically to check for all essential documentation
       Check 100% of SAE reports
       Audit the CRFs for 5 patients and cross reference with source
       Check storage facilities for study related material is appropriate
       Visit pharmacy and inspect drug accountability records for the study if
       Verify that the institution has adequate resources to conduct the study
       and that the CRFs are being submitted according to protocol timelines

Audit reports

An audit report will be produced within 4 weeks of the audit. This should
document the following:

       Identify audit team and members of the CTO or Institution who
       participated in the audit
       Site and scope of the audit
       Items audited
       Identification of any deficits or anomalies in study conduct and action
       taken – these should also be noted in a note to file, documenting the
       problem and the action taken, these should be filed in relevant study
       Plan for follow-up

All audit reports should be reviewed at a PCTC meeting.
All deficits or issues requiring intervention should be discussed with the senior
member of the CTO, or the PI of the institution, whichever is relevant.
All issues requiring action should be followed to resolution.
In cases of major issues the audit report should be discussed at Board level
and a decision taken on remedial strategies.

EU Directive 2001/20/EC
EU Directive 2004/28/EC


                Standard Operating Procedure for Audit Version 1: 9th June 2006

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