- Document No.:
- CMTFOI/REG/PIS/001
- Version:
- 1.0
- Effective Date:
- September 2026
- Status:
- Template authorised by the CMTFOI Board — each study must complete it and obtain ethics approval before use
- Owner:
- CMTFOI Registry — Privacy & Data Protection Contact
- Approval authority:
- CMTFOI Board (template); CMTFOI Scientific/Ethics authority, as applicable (per study)
- Next scheduled review:
- September 2027
- Review frequency:
- At least annually, and earlier where required by law, technology, governance requirements, or material changes to the Registry.
The scheduled review date is a governance review point. It does not mean the document ceases to apply after that date.
This template must be completed and approved for each individual research study before use. It is not the CMTFOI Patient Registry consent, and it does not describe any study that is currently running.
Template fields
- Study title: [STUDY TITLE]
- Study ID: [STUDY ID]
- Principal investigator: [PRINCIPAL INVESTIGATOR]
- Institution: [INSTITUTION]
- Sponsor or funder: [SPONSOR / FUNDER]
1. Purpose of the study
[STUDY PURPOSE — plain-language description of what the study is trying to find out.]
2. Why you are being invited
[WHY THIS PARTICIPANT IS INVITED — eligibility and how they were identified.]
3. What taking part involves
[PROCEDURES — visits, questionnaires, samples, duration, follow-up.]
4. Possible risks and burdens
[RISKS — including discomfort, time burden and privacy risk.]
5. Possible benefits
[BENEFITS — including a clear statement where there is no direct personal benefit.]
6. Information and samples collected
[DATA COLLECTED — categories of information and any biological samples.]
7. Genetic testing
[GENETIC TESTING — whether testing is performed, what results mean, and how findings are handled. Delete if not applicable.]
8. How your information will be shared
[DATA SHARING — recipients, de-identification approach and controls.]
9. International transfer
[INTERNATIONAL TRANSFER — countries involved and safeguards applied.]
10. Costs and compensation
[COMPENSATION / REIMBURSEMENT — or a statement that none is offered.]
11. Withdrawal
[WITHDRAWAL — how to withdraw and what happens to information already collected.]
12. Confidentiality
[CONFIDENTIALITY — how identity is protected and who may access identifiable information.]
13. Ethics approval
[ETHICS COMMITTEE / IRB NAME, APPROVAL REFERENCE AND DATE.]
14. Contact details
[STUDY CONTACT NAME, EMAIL, PHONE]. Registry privacy contact: privacy@cmtfoi.org.
15. Consent declaration
- I have read and understood the information about this study and have had the chance to ask questions.
- I understand that taking part is voluntary and that I can withdraw at any time.
- I agree to take part in [STUDY TITLE].
- Participant name, signature and date. Where applicable: parent or legal guardian name, relationship, signature and date; and participant assent where appropriate.