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ACCORD
NHS Lothian R&D and
The University of Edinburgh
SOP Number: CR007v2.0
Effective Date: 14/SEP/2011
PROTOCOL DEVELOPMENT AND AMENDMENTS
SOP NUMBER:
CR007
VERSION NUMBER: 2.0
EFFECTIVE DATE:
RELEASE DATE:
14/September/2011
31/August/2011
Signature
Date
AUTHOR: Gareth Thomas, Clinical Trials Monitor, ACCORD
30 th August
2011
APPROVED BY (1): Marise Buçukolu, University of Edinburgh, Head
of Research Governance
31 st August
2011
APPROVED BY (2): Dawn Lyster, QA Officer, ACCORD
31 st August
2011
REVIEWED BY: Louisa Wilson, Lynn Morrice
Parties using this SOP must visit www.accord.ed.ac.uk to guarantee adherence to the
latest version
Page 1 of 4

ACCORD
NHS Lothian R&D and
The University of Edinburgh
SOP Number: CR007v2.0
Effective Date: 14/SEP/2011
1. INTRODUCTION
The nature and conduct of a study will be described in a clear and detailed protocol.
Protocols will be written in accordance with the principles of Good Clinical Practice
(GCP) and will describe the objective(s), design, methodology, statistical
considerations and organisation of a study. Protocols must be carefully designed to
safeguard the health and safety of the participants, as well as answer specific
research questions.
All protocols must be submitted for approval from the applicable Research Ethics
Committee (REC), approval from the licensing authority (if required) and NHS R&D
management approval for the participating NHS sites. Any substantial amendments
made to the protocol must also be submitted for the required approvals.
Amendments cannot be enacted until the required approvals have been granted.
2. PURPOSE
To describe the procedure for writing a research protocol in accordance with ICH-
GCP E6 Guidelines and applicable regulatory requirements. This SOP describes
general principles of protocol development and amendments and provides a
template, primarily for Clinical Trials of Investigational Medicinal Products (CTIMPs).
3. SCOPE
This SOP applies to clinical researchers designing and participating in studies
sponsored by NHS Lothian and/or the University of Edinburgh (UoE). This SOP does
not apply to the design of clinical investigation plans/protocols for clinical
investigations of medical devices. This is described in the International Organisation
for Standardisation (ISO) standard 14155.
4. REFERENCES
Medicines for Human Use (Clinical Trials) Act 2004, Statutory Instrument 2004/1031
as amended
ICH-GCP E6 Guidelines
ISO 14155 Clinical Investigation of Medical Devices for Human Subjects
European Commission CT-1 communication (2010/C 82/01) – Detailed guidance on
the request to the competent authorities of a clinical trial on a medical product for
human use, the notification of substantial amendments and the declaration of the end
of the trial.
5. PROCEDURE
5.1 Protocol Contents
All protocols must be version controlled with the version number and date on the title
page. The protocol, and amendments, will be signed by the Chief Investigator (CI) to
Parties using this SOP must visit www.accord.ed.ac.uk to guarantee adherence to the
latest version
Page 2 of 4

ACCORD
NHS Lothian R&D and
The University of Edinburgh
SOP Number: CR007v2.0
Effective Date: 14/SEP/2011
denote agreement to conduct the study according to the protocol. Similarly the
protocol, and amendments, will be signed by Principal Investigators (PIs) at
investigator sites and by a representative of the sponsor(s). Furthermore, if there is
(a) study statistician(s), the lead statistician, or designee, will sign the protocol to
verify that the statistical plan and statistical rationale for the study are correct.
The protocol will include at least the following sections where applicable:
• General identifying information
• Background information
• Study objectives and purpose
• Endpoints
• Study design
• Study population
• Participant selection and enrolment
• IMP and placebo
• Non-IMP
• Clinical Investigational Agent(s)
• Study assessment including efficacy and safety
• Data collection, data handling and record keeping
• Statistics and data analysis
• Adverse events
• Pregnancy
• Trial oversight arrangements including quality control and quality
assurance procedures
• GCP adherance
• Study conduct and responsibilities
• Reporting, publications and notification of results
Some of this information may be listed in other protocol referenced documents, for
example, the Investigator’s Brochure.
Site specific information may be provided on (a) separate protocol page(s) or added
in a separate document.
5.2 Protocol preparation and control
Template CR007-T01 (Protocol Template) provides detailed guidance on writing a
study protocol. Investigators planning to run a CTIMP which will be sponsored or cosponsored
by NHS Lothian and/or the University of Edinburgh are required to use
this template and complete all the sections. Investigators planning to undertake a
study that is not a CTIMP are not required to use CR007-T01 however, such
investigators may use the template and delete sections that are not applicable, if
desired. Investigators planning to undertake a clinical investigation of a medical
device should design their clinical investigation plan/protocol in accordance with ISO
14155. If an investigator does not have access to ISO 14155, the Investigator should
contact the ACCORD office to discuss access.
If a heading does not apply, the Investigator will state “not applicable” under the
heading and provide a short explanation with respect to the reason(s) why the
heading does not apply. All protocols for CTIMPs which will be sponsored or cosponsored
by NHS Lothian and/or the UoE will be subject to review by ACCORD
Quality Assurance personnel (accord.qa@ed.ac.uk). Other study protocols may also
be submitted for review if agreed by ACCORD Quality Assurance personnel.
Parties using this SOP must visit www.accord.ed.ac.uk to guarantee adherence to the
latest version
Page 3 of 4

ACCORD
NHS Lothian R&D and
The University of Edinburgh
SOP Number: CR007v2.0
Effective Date: 14/SEP/2011
The study Case Report Forms (CRFs), the Participant Information Sheet (PIS) and
any other relevant study information must be consistent with the protocol.
Guidance from ACCORD staff members will be provided to researchers, with respect
to protocol design, in line with SOPs: FA001 – Study Facilitation and QA004 – Study
Document Review.
The CI will ensure that the latest version of the protocol is provided to all PIs,
together with any relevant explanatory information. PIs will ensure that local
investigator site study team members are fully cognisant with the study protocol as
applicable.
5.3 Amendments
The CI will ensure that the protocol is amended to reflect any new study procedures.
For substantial amendments, the CI will ensure that any new/amended procedures
are not enacted before approval has been received from the sponsor(s) and that the
amended protocol has received all of the required approvals e.g. REC, licensing
authority, local NHS R&D. The notion of substantial amendments and specific
examples that require approval are described in section 3 of the European
Commission CT-1 communication (2010/C 82/01).
6. RELATED DOCUMENTS
• FA001 Study Facilitation
• QA004 Study Document Review
• CR007-T01 Protocol Template
7. DOCUMENT HISTORY
Version Effective Reason(s) for change(s):
Number: Date:
1.0 22/Mar/2011 New Procedure
Parties using this SOP must visit www.accord.ed.ac.uk to guarantee adherence to the
latest version
Page 4 of 4