SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents* Description Administrative information Title 1 Descriptive title identifying the study design, population, interventions, and, if applicable, trial acronym Dedicated mobile application for drug adverse reactions reporting by patients with relapsing remitting multiple sclerosis: study protocol for a multicenter cluster-randomized controlled trial (Vigip-SEP study) Trial 2a Trial identifier and registry name. If not yet registered, name of intended registry TRIAL REGISTRTATION: ClinicalTrials.gov, identifier: NCT03029897. Registered on 20 January 2017. 2b All items from the World Health Organization Trial Registration Data Set Yes Protocol version 3 Date and version identifier Approved version of VigiP-SEP is V3 29.11.2016, the recruitment began on June 2017, and the end date is anticipated in May 2018. Funding 4 Sources and types of financial, material, and other support The funding is provided by the Regional Health Agency of Normandy (ARS Normandie) and by the RBN-SEP Association, an association about multiple sclerosis. Funders have no implication in the collection, management, analysis, and interpretation of the data. Item No
12 Primary, secondary, and other outcomes, including the specific measurement variable (eg, systolic blood pressure), analysis metric (eg, change from baseline, final value, time to event), method of aggregation (eg, median, proportion), and time point for each outcome. Explanation of the clinical relevance of chosen efficacy and harm outcomes is strongly recommended Done timeline 13 Time schedule of enrolment, interventions (including any and washouts), assessments, and visits for participants. A schematic diagram is highly recommended (see Figure) Done Sample size 14 Estimated number of participants needed to achieve study objectives and how it was determined, including clinical and statistical assumptions supporting any sample size calculations Done 15 Strategies for achieving adequate participant enrolment to reach target sample size Done Methods: Assignment of interventions (for controlled trials) Done 16a Method of generating the allocation sequence (eg, computer-generated random numbers), and list of any factors for stratification. To reduce predictability of a random sequence, details of any planned restriction (eg, blocking) should be provided in a separate document that is unavailable to those who enrol participants or assign interventions
Harms 22 Plans for collecting, assessing, reporting, and managing solicited and spontaneously reported adverse events and other unintended effects of trial interventions or trial conduct Reporting of adverse event is the object of the study. Experimental intervention “introduction to the App” is not a risk for patients included in VigipSEP, so a safety monitoring board is not necessary. Auditing 23 Frequency and procedures for auditing trial conduct, if any, and whether the process will be independent from investigators and the sponsor Sponsor CHU de Caen applies a random auditing of their trials on these low risk studies. Ethics and dissemination ethics approval 24 Plans for seeking research ethics committee/institutional review board (REC/IRB) approval Approved by CPP Protocol 25 Plans for communicating important protocol modifications (eg, changes to eligibility criteria, outcomes, analyses) to relevant parties (eg, investigators, REC/IRBs, trial participants, trial registries, journals, regulators) Done Consent or assent 26a Who will obtain informed consent or assent from potential trial participants or authorised surrogates, and how (see Item 32) Done 26b Additional consent provisions for collection and use of participant data and biological specimens in ancillary studies, if applicable NA 27 How personal information about potential and enrolled participants will be collected, shared, and maintained in order to protect confidentiality before, during, and after the trial Done (CNIL) of interests 28 Financial and other competing interests for principal investigators for the overall trial and each study site Done