SOP 320 Developing A Research Protocol

SOP 320, Developing a Research Protocol
For Use in: Research & Development
By: All staff

For: All staff involved in the conduct of research
Division responsible for document: Research & Development
Key words: Developing a Research Protocol

Name of document author: Gillian Short
Job title of document author: Research Governance Coordinator
Name of document author’s Line
Julie Dawson
Manager:
Job title of author’s Line Manager: Research Services Manager
Julie Dawson NNUH
Supported by:
Sarah Ruthven UEA
Julie Dawson: Research Services Manager

Assessed and approved by the: NNUH
Sarah Ruthven: Research Manager UEA
Date of approval: 24th October 2019

To be reviewed before:
24/10/2022 (3 years, unless legislation or process
This document remains current after this
changes)
date but will be under review
Reference and / or Trust Docs ID No: 13855
Version No: 2.2
Change of title
Description of changes: Section 7 updated to clarify NCTU process
General update and new template
SOP 320 v2.2
This Standard Operating Procedure (SOP) is available on the Research & Development
pages on the NNUH website
Copies printed from the website are only valid on the day of printing.
Standard Operating Procedure for: 320 Writing a Proposal and Developing a Research Protocol
Author/s: Gillian Short Author/s title: Research Governance Coordinator
Approved by: Julie Dawson/Sarah Ruthven Date approved: 24/10/2019 Review date: 24/10/2022
Available via Trust Docs Version: 2.2 Trust Docs ID: 13855 Page 1 of 12
SOP 320 Writing a Proposal and Developing a Research
1. Contents
Section Page
1. Contents 2
2. Definitions of Terms Used / Glossary 2
3. Scope 2
4. Introduction 3
5. Rules 3
6. Procedure for NNUH 4
7. Procedure for UEA and NCTU 5
8. Appendix 1 - Guidance for protocol structure for non 6
CTIMPs
9. Appendix 2 - Requirements for a protocol structure for 10
CTIMPs and/or Medical Device Trials and Further Guidance
10. Approval 13
11. Reason for Update & Training Implication 13
2. Definitions of Terms Used / Glossary
CI Chief Investigator
CTA Clinical Trials Agreement
CTIMP Clinical Trial of an Investigational Medicinal Product
EU European Union
GCP Good Clinical Practice
HRA Health Research Authority
NCTU Norwich Clinical Trials Unit
NNUH Norfolk and Norwich University Hospitals NHS Foundation Trust
R&D Research and Development
SOP Standard Operating Procedure
UEA University of East Anglia
3. Scope
This SOP describes the process for writing health care research proposals
and protocols by researchers at NCTU, UEA and NNUH
4. Introduction
This process aims to ensure the research team has the correct guidance to enable
production of protocols for research studies. Research is carefully designed to
safeguard the health and safety of the participants in compliance with the conditions
and principles of Good Clinical Practice (GCP) and the applicable EU guidelines and
regulations.
5. Rules
A research protocol is an essential document

which provides the research team with a plan for
undertaking the study
• A protocol is a legal document that, once approved by regulatory

and ethical bodies, all parties and organisations involved in the
study agree to comply with
• Investigators should sign and date the signature page of the
current protocol and organisations should refer to the protocol in
their agreements about the study
• The protocol must be written by the Research Team prior to
applying for any approval and prior to starting the study
6. Procedure for Research Protocol Development
Prior to the start of a study the protocol should be developed in accordance with the
Health Research Authority (HRA) guidelines and that of the lead NHS Trust
Where the study is adopted

The protocol should be version controlled (see by the NCTU, the NCTU will
SOP 865 Study Specific Document need to be involved in the
Management) development
The final version of the protocol must be reviewed, amended and approved by the
Research Team, to include: the Chief Investigator (CI), statistician and pharmacist (the
latter two roles being essential for CTIMPs)
For studies involving a health economic

analysis, the analysis output should also be
reviewed by the Health Economist
The final version of the protocol sent for regulatory and ethical approval should be
signed and dated by the CI and stored in the Trial Master File (see SOP 305 Creating
and Maintaining a Trial Master File)
The process for approval of the protocol for ethical and research governance review is
part of the start-up activities for a Clinical Trial (SOP 325), confirmation of Sponsorship
of Research (SOP 400), and obtaining MHRA approval for CTIMPs and Medical
Devices trials (SOP405)
An early version of the protocol may be updated following comments and feedback
from regulatory bodies prior to the start of the project. All versions should be signed
and dated and stored in the TMF. Guidance on the content of the protocol is provided
in Appendix 1 (non CTIMPs), Appendix 2 (CTIMPs).
The process for seeking approval for amendments to the research protocol is
Detailed in:
 SOP 215 (Research Study Amendments)

 SOP 405 (Obtaining and Maintaining Medicines and Healthcare Products
Regulatory Approvals Agency (MHRA) Approval for a Clinical Trial).
7. Procedure for UEA and CTU
Procedure will be as defined in the local working practice documentation.
Where the CTU has delegated responsibility for developing the research protocol; the
CTU research protocol template maybe used; with Sponsor approval.
8. Appendix 1 Guidance for protocol structure for non CTIMPs
Protocol Identification, code number, version numbers and dates, signatures
Protocol code number
• A protocol code number is unique for each study and required on

each protocol
• The Sponsor must have input into the code used
Protocol version number and dates
• Allocate version numbers and dates for protocols during the

drafting process
• The final protocol that is submitted to the ethics committee should
be numbered as version 1.0 and dated with the date of finalisation
• If protocol amendments are made, the protocol version number
and date must be updated
Protocol signature
• The protocol and amendments must be signed by the Sponsor

• Provide name and title of person(s) authorised to sign the protocol
and a signature and date block
Protocol requirements:
a) Title:
The title clearly identifies the study and contains a brief description of the study design
and objectives.
b) Investigators:
List everyone who has made a material contribution to the design of at least one
component of the study.
Include name and contact details.
c) Abstract/Summary
Summarise the objectives of the study.
Give a brief outline of the design and methods.
d) Introduction
Outline the background to the research; include a critical review of the current
knowledge or literature, including published and unpublished work in the area.
Gaps in the evidence should be identified; as should the potential value of furthering
knowledge in this field, such as theoretical or practice based applications of the
potential research outcomes.
An explanation of the reasons for undertaking the work should be included in this
section, incorporating a reflective stance whereby the researcher/s reflect upon their
reasons for undertaking the research and interest in the field.
e) Objectives:
Outline broad objectives that should follow on from the identified gaps in the literature
and rationale for the study.
Stated objectives should allow for unexpected emergent findings to be incorporated as

part of the research findings.
f) Study Design:
Provide summary of study design which will answer particular research question.
g) Location of study:
What is the location of the study and any specific tasks.
f) Participants:
Information regarding participants should be provided:
 Expected study population, including a rationale of why they are relevant to your
research question(s).
 Methods by which participants will be identified and recruited and what criteria will
be used for deciding whether or not individuals are eligible to participate.
 Expected sample size and justification.
 Nature of expected adverse events along with the reporting procedures that will be
used.
 Assessment and follow up requirements
 End of the study schedule and requirements
 Consent process and relevant timelines
 Issues such as the potential transferability of results to alternative populations.
h) Sampling methods:
Sampling methods and justifications may be framed in terms of gaining access to

particular populations, or in terms of fit with the research design.
i) Methods of data collection:
 What data will be collected

 Reason for data collection
 Method of collection
 Schedule for collection
j) Data Management & Analysis
 Method of data recording

 Collection
 Management and access
 Statistical Analysis Plan (SAP) including assumptions of analysis
 Data analysis package
 Reporting of data and statistical analysis results
 Electronic data capture, analysis and reporting
k) Study Administration & Ethical Issues
 Arrangements for the day-to-day management of the study.
 Methods by which the participants’ interests will be safeguarded. For example; the
process of risk limitation; how you will maintain confidentiality or anonymise
participants’ data and how you will deal with any apparent psychological harm
 State whether there has been user involvement in design of the study, and whether
user involvement will be incorporated as an ongoing aspect of the research.
 State whether you have adhered to any set of ethical guidelines
 Any proposal should clearly state who is funding the research study and what
interest they have in its outcome.
 Confirm the sponsorship arrangements for the study.
l) Resource Requirements:
 Resource implications to the host organisation

 Other departments
 Outline the timetable/schedule of the research and costs.
m) Study Plan:
A study plan or flow chart showing a brief summary of the order, site and timing of all
procedures may be included.
n) Supervision for student projects:
The protocol should name any individual(s) who will supervise the research project and
the intended arrangements for the supervision.
o) Dissemination & Outcome (SOP 340 Clinical Trial reporting):
Reporting of study findings:
 Publish or present the findings including any report of findings to the participants.
 Any implications for future practice and theoretical knowledge advancement should
also be suggested.
p) Archiving of study records and data (SOP 900 Archiving, retrieval and
destruction of Research Documents):
 Location of archive for principal location, vendor and site locations

 Period of archiving
9. Appendix 2 Requirements for a protocol structure for CTIMPs and/or Medical

Device Trials and Further Guidance
The contents of a trial protocol for a CTIMP

and/or Medical Device Trial should include the
following information:
• General background information

• Trial objective and purpose
• Trial design
• Selection of sites/clinicians
• Selection and withdrawal of participants
• Randomisation and Unblinding
• Treatment of participants
• Assessments and Follow-Up (efficacy, safety and quality of life)
• Safety Reporting and Follow-Up
• Statistics
• Direct access to source data/documents
• Quality control and quality assurance (risk assessment,
monitoring)
• Regulatory issues (Clinical Trials Agreement) CTA, ethics, consent,
confidentiality, indemnity, sponsor, funding, audit & inspection))
• Data handling and record keeping
• Archiving location and period
• Trial Management
• Publication and reporting
• References
• Appendices
Protocol identification: code number, version number and dates, signatures
Protocol code number
• A code unique number is required on each protocol

• The protocol code number should be in place when the EudraCT number is
issued
• Previous code numbers for other trials must not be used; e.g. trial acronym
and year (MAG98) or the ISRCTN number
Protocol version number and dates
• Allocate a version number and version dates to protocols during the drafting
process
• The final protocol that is submitted to the ethics committee should be
numbered as version 1.0 and dated with the date of finalisation
• If protocol amendments are made, the protocol version number and date
must be updated
Protocol signature
• The protocol and amendments must be signed by the Sponsor

• Provide name and title of person(s) authorised to sign the protocol and a
signature and date block
a) Other General Information:
 Provide names & addresses of key study personnel

 Provide names & addresses of clinical laboratories, drug supply organizations
and any other institutions involved in the trial.
b) Other guidance for good protocol development:
Include Risk Assessment for the study (SOP 700 Risk Assessment and SOP 725
Capacity, Capability and Risk Assessment).
c) Safety Reporting:
ICH GCP requires that both investigators and sponsors follow specific
procedures when reporting adverse events/reactions in clinical trials involving
IMPs. These procedures should be described un-ambiguously in the safety

section of the protocol and may require additional documents that should be
referred to in this section e.g.:
 The trial safety management plan (SmPC)
 Reference Safety Information (RSI)
 The Sponsor is responsible for providing this information for this section.
See SOP 205 Adverse Events: Identifying, Recording and Reporting for CTIMPs and
Device Trials.
d) Protocol amendments:
See SOP 215 Research Study Amendments.
10. Approval
Author: Gillian Short

Role: Research Governance Coordinator
Signature: Gillian Short
Date: 23/10/2019
Approved & Authorised NNUH: Julie Dawson
Role: Research Services Manager
Signature: Julie Dawson
Date: 23/10/2019
Approved & Authorised UEA: Sarah Ruthven
Role: Research Manager
Signature: Sarah Ruthven
Date: 24/10/2019
11. Reason for Update and Training Implication
This replaces SOP 320 v 2.1
Update Reason Training Action

Implication
Section 7 Response to Yes Review SOP and update training matrix
updated to clarify regulatory
CTU and UEA inspection and new
process template update
General update
and
reformatting

SOP 320 Developing A Research Protocol

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SOP 320, Developing a Research Protocol

For Use in: Research & Development

By: All staff

Key words: Developing a Research Protocol

Julie Dawson: Research Services Manager

Date of approval: 24th October 2019

SOP 320 v2.2

2. Definitions of Terms Used / Glossary

A research protocol is an essential document

• A protocol is a legal document that, once approved by regulatory

6. Procedure for Research Protocol Development

Where the study is adopted

For studies involving a health economic

 SOP 215 (Research Study Amendments)

8. Appendix 1 Guidance for protocol structure for non CTIMPs

Protocol Identification, code number, version numbers and dates, signatures

Protocol code number

• A protocol code number is unique for each study and required on

Protocol version number and dates

• Allocate version numbers and dates for protocols during the

• The protocol and amendments must be signed by the Sponsor

Include name and contact details.

Summarise the objectives of the study.

Give a brief outline of the design and methods.

Stated objectives should allow for unexpected emergent findings to be incorporated as

What is the location of the study and any specific tasks.

Information regarding participants should be provided:

Sampling methods and justifications may be framed in terms of gaining access to

i) Methods of data collection:

 What data will be collected

j) Data Management & Analysis

 Method of data recording

k) Study Administration & Ethical Issues

 Arrangements for the day-to-day management of the study.

 Resource implications to the host organisation

n) Supervision for student projects:

o) Dissemination & Outcome (SOP 340 Clinical Trial reporting):

Reporting of study findings:

 Location of archive for principal location, vendor and site locations

9. Appendix 2 Requirements for a protocol structure for CTIMPs and/or Medical

The contents of a trial protocol for a CTIMP

• General background information

Protocol identification: code number, version number and dates, signatures

Protocol code number

• A code unique number is required on each protocol

Protocol version number and dates

• The protocol and amendments must be signed by the Sponsor

a) Other General Information:

 Provide names & addresses of key study personnel

b) Other guidance for good protocol development:

IMPs. These procedures should be described un-ambiguously in the safety

See SOP 215 Research Study Amendments.

Author: Gillian Short

11. Reason for Update and Training Implication

This replaces SOP 320 v 2.1

Update Reason Training Action

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