Study logo/Sponsor logo/Funder logo

FULL/LONG TITLE OF THE STUDY

SHORT STUDY TITLE / ACRONYM

PROTOCOL VERSION NUMBER AND DATE

  • This protocol has regard for the HRA guidance and order of content

RESEARCH REFERENCE NUMBERS

IRAS Number:
ISRCTN / Clinical trials.gov Number:
SponsorNumber:
Funder’s Number:

SIGNATURE PAGE

The undersigned confirm that the following protocol has been agreed and accepted and that the Chief Investigator agrees to conduct the trial in compliance with the approved protocol, GCP guidelines, the Sponsor’s SOPs, and other regulatory requirements as amended.

I agree to ensure that the confidential information contained in this document will not be used for any other purpose other than the evaluation or conduct of the clinical investigation without the prior written consent of the Sponsor

I also confirm that I will make the findings of the study publically available through publication or other dissemination tools without any unnecessary delay and that an honest accurate and transparent account of the study will be given; and that any discrepancies from the study as planned in this protocol will be explained.

For and on behalf of the Study Sponsor:
Signature:
...... / Date: ...... /...... /......
Name (please print):
......
Position: ......
Chief Investigator:
Signature: ...... / Date: ...... /...... /......
Name (please print):
......

LIST of CONTENTS

GENERAL INFORMATION / Page No.
TITLE PAGE
RESEARCH REFERENCE NUMBERS
SIGNATURE PAGE
LIST of CONTENTS
LIST OF ABBREVIATIONS
KEY TRIAL/STUDY CONTACTS
TRIAL/STUDY SUMMARY
TRIAL FLOW CHART
SECTION
1. BACKGROUND
2. RATIONALE
3. OBJECTIVES AND OUTCOME MEASURES/ENDPOINTS
4. TRIAL DESIGN
5. STUDY SETTING
6. ELIGIBILITY CRITERIA
7. TRIAL/STUDY* PROCEDURES
8. STATISTICS AND DATA ANALYSIS
9. DATA HANDLING
10. MONITORING AUDIT
11.ETHICAL AND TRIAL ADMINISTRATION
12. DISSEMINATION POLICY
13. REFERENCES
14. APPENDICIES

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LIST OF ABBREVIATIONS* Items as appropriate

Define all unusual or ‘technical’ terms related to the trial/study*. Add or delete as appropriate. Maintain alphabetical order for ease of reference.

AEAdverse Event

ARAdverse Reaction

CIChief Investigator

CRFCase Report Form

CROContract Research Organisation

CTAClinical Trial Authorisation

DMCData Monitoring Committee

DSURDevelopment Safety Update Report

GCPGood Clinical Practice

ICFInformed Consent Form

DMCIndependent Data Monitoring Committee

ISFInvestigator Site File

ISRCTNInternational Standard Randomised Controlled Trials Number

NIMPNon-Investigational Medicinal Product

PIPrincipal Investigator

PICParticipant Identification Centre

PISParticipant Information Sheet

QAQuality Assurance

QCQuality Control

RCTRandomised Control Trial

RECResearch Ethics Committee

SAESerious Adverse Event

SARSerious Adverse Reaction

SDVSource Data Verification

SMF*Study Master File

SMG*Study Management Group

SOPStandard Operating Procedure

SSISite Specific Information

SUSARSuspected Unexpected Serious Adverse Reaction

TMG*Trial Management Group

TSCTrial Steering Committee

TMF*Trial Master File

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KEY TRIAL/STUDY* CONTACTS

*Delete as appropriate

Insert full details of the key trial contacts including the following (where applicable)

Chief Investigator / Full contact details including phone, email and fax numbers
Principal Investigator / Full contact details including phone, email and fax numbers
Sponsor / Dr Clark Crawford
Head of Research Integrity, Directorate of Engagement & Partnerships, Innovation Centre 2, Keele University, Staffordshire, ST5 5NH
01782 733371

Joint-sponsor(s)/co-sponsor(s) / Full contact details including phone, email and fax numbers of ALL organisations assuming sponsorship responsibilities as a joint- or co-sponsor/s (If applicable)
Funder(s) / Names and contact details of ALL organisations providing funding and/or support in kind for this trial
Trial/Study* Management / Keele Clinical Trials Unit (CTU), David Weatherall Building, Keele University, Staffordshire, ST5 5BG
01782 732916

Key Protocol Contributors / Full contact details including phone, email and fax numbers (If applicable)
Lead Statistician / Full contact details including phone, email and fax numbers
Committees / Full contact details including phone, email and fax numbers

Page 1 of 11 TEM73 Keele CTU Non-CTIMP Protocol Template v1.006-Feb-2017

TRIAL/STUDY* SUMMARY

It may be useful to include a brief synopsis of the trial/study for quick reference. Complete information and, if required, add additional rows.

Trial/Study* Title
Internal Ref. Number (or short title)
Trial/Study* Design
Trial Intervention (where applicable)
Trial/Study* Participants
Planned Sample Size
Treatment duration
Follow up duration
Planned Trial Period
Objectives / Outcome Measures
Primary
Secondary

TRIAL/STUDY* FLOW CHART

1BACKGROUND

2RATIONALE

3OBJECTIVES AND OUTCOME MEASURES/ENDPOINTS

3.1Primary objective

3.2Secondary objectives

3.3Outcome measures/endpoints

3.4Primary endpoint/outcome

3.5Secondary endpoints/outcomes

3.6Exploratory endpoints/outcomes

4TRIAL/STUDY* DESIGN

4.1Interventions/Treatments

4.2Study Training

5STUDY SETTING

6ELIGIBILITY CRITERIA

6.1Inclusion criteria

6.2Exclusion criteria

7TRIAL/STUDY* PROCEDURES

7.1Recruitment

7.1.1 Patient identification

7.1.2Screening

7.2 Consent

7.3The randomisation scheme

7.4Blinding

7.5Unblinding

7.6Baseline data

7.7Trial/Study* assessments

7.8Long term follow-up assessments

7.9Qualitative assessments – Nested studies

7.10Withdrawal criteria

7.11Storage and analysis of samples

7.12End of trial/study*

8STATISTICS AND DATA ANALYSIS

8.1Sample size calculation

8.2Planned recruitment rate

8.3Statistical analysis plan

8.3.1Summary of baseline data and flow of patients

8.3.2Primary outcome analysis

8.3.3Secondary outcome analysis

8.4Subgroup analyses

8.5Adjusted analysis

8.6Interim analysis and criteria for the premature termination of the trial

8.7 Subject population

8.8 Procedure(s) to account for missing or spurious data

8.9Other statistical considerations.

8.11Economic evaluation

9DATA HANDLING

9.1Data collection tools and source document identification

9.2Data handling and record keeping

9.3Access to Data

9.4Data Sharing Agreements

9.5Archiving

10MONITORING AUDIT

10.1Trial/Study* Management

10.1.1Trial Steering Committee (TSC) members

10.1.2Data Monitoring Committee (DMC) members

10.2 Monitoring arrangements

10.3Auditing procedures

10.4Safety Reporting

10.5Trial timeline

11ETHICAL AND REGULATORY CONSIDERATIONS

11.1 Research Ethics Committee (REC) review& reports

11.2 Peer review

11.3 Public and Patient Involvement

11.4 Regulatory Compliance

11.5 Protocol compliance

11.6 Notification of Serious Breaches to GCP and/or the protocol

11.7 Data protection and patient confidentiality

11.8 Financial and other competing interests for the chief investigator, PIs at each site and committee members for the overall trial/study* management

11.9 Indemnity

11.10 Amendments

11.11 Post trial care

11.12 Access to the final trial dataset

12DISSEMINIATION POLICY

12.1 Dissemination policy

12.2 Authorship eligibility guidelines and any intended use of professional writers

13REFERENCES

14. APPENDICIES

14.1Appendix 1 - Study management / responsibilities

(For multi-centre trials/studies* only)

Page 1 of 11 TEM73 Keele CTU Non-CTIMP Protocol Template v1.006-Feb-2017