Table 3 Summary of amendments
Amendment number, date of ethics committee approval | Summary of amendment (see Appendix 1 for full details of all substantial amendments) |
|---|---|
1. 29 January 2016 | Amendments were made to the consent to study forms for parents of participants age 16–17: Participants aged 16–17 did not need parents to consent on their behalf; however, parents were being asked to complete parental questionnaires and needed to provide consent to this research procedure. A consent form for parents/carers of young people aged 16–17 years was added. Amendments were made to the consent to study forms: We intended to use data collected during the feasibility study for the full-scale trial. This was stated in the protocol and the participant information sheets. The consent to study form was updated to reflect this. Amendments were made to the protocol: We amended the protocol to allow qualitative interviews via Skype. Amendment were made to the consent to contact, and consent to discussion forms: Changed wording and field added. |
2. 31 March 2016 | Amendments were made to the protocol: Amendments were made to protocol in response to reviewers’ comments upon the publication of the MAGENTA feasibility protocol. This included changes to the background information, aims and objective, the methods, adding stop-go criteria and safety outcomes. |
3. 27 July 2016 | Amendments were made to the health economics forms: We amended the forms due to poor response rate. We developed a second version of the baseline, 6-month and 12-month questionnaires. The new forms continued to capture our primary outcomes. Amendments were made to the protocol to document the closing down the Cambridge Site: We were unable to recruit from the Cambridge site and documented the sites closure in the protocol. Amendments were made to the protocol: We changed wording in the protocol to provide further detail and clarification in the background and methods sections. |