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Information on Transcranial Magnetic Stimulation Research Protocol Template
This protocol template has been designed for use in projects which are being conducted
under the generic CUREC approval.
The template is available for use by all investigators who are carrying out research within the
Medical Sciences Division and should accompany the checklist when submitted to CTRG for
review.
Review by CTRG will confirm indemnity for the project as the details will be added to the
database which is used for annual insurance returns.
All advisory texts are highlighted in yellow. These should all be deleted before the document
is finalised.
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TMS Protocol Template v1.0
The University of Oxford 2012
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Study Title: insert full title including brief reference to the design and what is
being studied, and primary objective
Internal Reference No This should be assigned by the investigator/department
Date and Version No: Insert
Chief Investigator:
Insert name and contact details.
Investigators:
Insert names of key collaborators
Funder (if applicable):
Insert details of organisation providing funding
Signatures:
The approved protocol should be signed by author(s) and/or
person(s) authorised to sign the protocol
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TABLE OF CONTENTS
To update table of contents (TOC), hover cursor over the top left hand corner until the whole
TOC highlights. Press the ‘F9’ button. Choose ‘update entire table’.
1.
SYNOPSIS .....................................................................................................................4
2.
ABBREVIATIONS ..........................................................................................................4
3.
BACKGROUND AND RATIONALE ................................................................................5
4.
OBJECTIVES .................................................................................................................5
5.
4.1
Primary Objective ....................................................Error! Bookmark not defined.
4.2
Secondary Objectives ..............................................Error! Bookmark not defined.
STUDY DESIGN ............................................................................................................5
5.1
Summary of Study Design ......................................................................................5
5.2
Primary and Secondary Endpoints/Outcome Measures ..........................................5
5.3
Study Participants...................................................................................................5
5.4
Study Procedures ...................................................................................................6
5.5
Definition of End of Study .......................................................................................6
6.
INTERVENTIONS ..........................................................................................................7
7.
SAFETY (if applicable) ...................................................................................................7
7.1
8.
9.
Reporting Procedures for Serious Adverse Events .................................................7
STATISTICS AND ANALYSIS ........................................................................................7
8.1
Number of Participants ...........................................................................................7
8.2
Analysis of Endpoints .............................................................................................8
ETHICS ..........................................................................................................................8
9.1
Participant Confidentiality .......................................................................................8
9.2
Other Ethical Considerations ..................................................................................8
10. DATA HANDLING AND RECORD KEEPING .................................................................8
11. FINANCING AND INSURANCE .....................................................................................8
11.1
Funding ..................................................................................................................8
11.2
Indemnity ................................................................................................................8
12. REFERENCES ...............................................................................................................9
13. APPENDIX A: STUDY FLOW CHART .........................................................................10
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TMS Protocol Template v1.0
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SYNOPSIS
It may be useful to include a synopsis of the study for quick reference. Delete or alter as
appropriate/required.
Study Title
Internal ref. no.
Study Design
Study Participants
Number of
Participants
Planned Study
Period
Primary Objective
Secondary
Objectives
Primary Endpoint
Secondary
Endpoints
Intervention (s)
2.
ABBREVIATIONS
Add or delete as appropriate.
CI
Chief Investigator
CTRG
Clinical Trials & Research Governance, University of Oxford
CUREC
Central University Research Ethics Committee
GCP
Good Clinical Practice
ICF
Informed Consent Form
PI
Principal Investigator
PIL
Participant/ Patient Information Leaflet
SOP
Standard Operating Procedure
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BACKGROUND AND RATIONALE
Outline the scientific justification for the research. Give an outline of the background to
the study, with references to literature and other relevant research.
Give an outline of the main research questions. Give a brief outline of the intervention
(if applicable) and summary of findings from previous studies (if relevant) that
potentially have significance.
Provide summary of the known and potential risks and benefits of any of the study
procedures (where applicable).
Describe the population to be studied.
Include references as appropriate.
4.
OBJECTIVES
List all the objectives of the study
The wording of the objectives should be clear, unambiguous and as specific as
possible.
5.
STUDY DESIGN
5.1
Summary of Study Design
Describe the overall study design e.g. sham-controlled, parallel design, observational,
qualitative.
Give the expected duration of participant participation, number of visits, and a
description of the sequence and duration of all study periods.
5.2
Endpoints/Outcome Measures
Describe the end-points/outcome measures and how/when they will be measured
during the study.
Endpoints/outcome measures should reflect the objectives. It is important that only one
primary endpoint/outcome measure is selected as it will be used to decide the overall
results or ‘success’ of the study. The endpoint/outcome measures should be
measurable, relevant to participants and widely accepted by the scientific community.
5.3
Study Participants
5.3.1 Overall Description of Study Participants
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Give an overall description of the study participants.
Example:
Healthy adults aged <<insert age>>.
5.3.2 Inclusion Criteria
Example criteria (amend as appropriate):

Participant is willing and able to give informed consent for participation in the study.

Healthy Male or Female, aged 18 to 85 years.

Additional criteria as required.
5.3.3 Exclusion Criteria
The participant may not enter the study if ANY of the following apply:
5.4

Specify any conditions that would preclude entry into the study

Contraindications to TMS (including but not limited to a history of epilepsy)

History of neurological or psychiatric illness

Pregnancy or are likely to become pregnant during the study

Additional criteria as required.
Study Procedures
Describe all study procedures and assessments in detail. Add visit numbers as
appropriate. Add schedule of procedures as an appendix if appropriate.
5.4.1 Informed Consent
It should be specified who will take informed consent and how and when it will be
taken. Informed consent must be obtained prior to any study related procedures being
undertaken.
5.4.2 Study Assessments
List and describe each assessment specifying time points. Include screening and
eligibility assessment, baseline and subsequent assessments.
5.5
Definition of End of Study
The definition of end of study must be provided. In most cases the end of study will be
the date of the last visit of the last participant. Any exceptions should be justified.
Example:
The end of study is the date of the last <<visit / telephone follow up / home visit>>of
the last participant.
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INTERVENTIONS
Describe interventions (if applicable) including the name(s) of procedure, intervention
schedule(s), if applicable.
Example:
Brain stimulation interventions: Once contraindications to transcranial magnetic
stimulation (TMS) are excluded, the risks of taking part in a TMS study are minimal. An
experienced researcher will go through a list of possible risks with the participant
before the study and answer any questions. The TMS coil contains metal wire wound
in a circular or figure of eight configuration. To stimulate, a very brief electrical current
is discharged through the coil creating a very rapidly changing magnetic field around
the coil that will induce a current in any conductive material near the coil. When placed
on the head, the nearest conductors are neurons in the cortex of the brain. When the
coil discharges, the participant may hear a loud click. Because this occurs close to the
ear, the participant is usually given earplugs or protective headphones through which
auditory stimuli can be played. Some people may find the brain stimulation painful
depending on the coil placement. Researchers will attempt to find a coil orientation
that minimizes discomfort for the participant. During the whole duration of the
experiment, the participant is able to talk with the researchers and indicate any
discomfort. The participant will be assured that they can withdraw from the study for
any reason without penalty.
7.
SAFETY (IF APPLICABLE)
Consider whether the study methodology, especially interventions or investigations
may be associated with any serious adverse events.
7.1
Reporting Procedures for Serious Adverse Events
Serious adverse events must be reported to the IDREC which approved your
application within seven days study where in the opinion of the Chief Investigator the
event was: ‘related’ – that is, it resulted from administration of any of the research
procedures; and ‘unexpected’ – that is, the type of event is not listed in the protocol as
an expected occurrence.
8.
STATISTICS AND ANALYSIS
8.1
Number of Participants
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State the approximate number of participants required with justification.
8.2
Analysis of Endpoints
Describe analysis of primary and secondary endpoints.
9.
ETHICS
Describe ethical considerations relating to the study. Include general and study specific
ethical considerations.
9.1
Participant Confidentiality
Example:
The study staff will ensure that the participants’ anonymity is maintained.
The
participants will be identified only by an ID number on any electronic database. All
documents will be stored securely and only accessible by study staff and authorised
personnel. The study will comply with the Data Protection Act which requires data to be
anonymised as soon as it is practical to do so.
9.2
Other Ethical Considerations
Include any ethical considerations specific to the study e.g. use of deception in study
procedures.
10. DATA HANDLING AND RECORD KEEPING
Describe method of data entry/management
Example:
All study data will be entered on a <<quote software and validation procedure>>. The
participants will be identified by a study specific participants number and/or code in any
database. The name and any other identifying detail will NOT be included in any study
data electronic file.
11. FINANCING AND INSURANCE
11.1 Funding
Describe financing arrangements.
11.2 Indemnity
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The University has arrangements in place to provide for harm arising from participation
in the study.
12. REFERENCES
Insert references used in text (preferably in alphabetical order of first author).
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13. APPENDIX A: STUDY FLOW CHART
Optional
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The University of Oxford 2012
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