1 2 3 spirit SPIRIT Standard Protocol Items

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3 spirit SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) is an international initiative

3 spirit SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) is an international initiative that aims to improve the quality of clinical trial protocols by defining an evidence-based set of items to address in a protocol.

4 About SPIRIT In 2007, an international group of stakeholders (the SPIRIT Group) launched

4 About SPIRIT In 2007, an international group of stakeholders (the SPIRIT Group) launched the SPIRIT initiative to help improve the completeness and quality of trial protocols. The evidencebased SPIRIT recommendations were developed using systematic, transparent methodology and broad consultation with 115 experts representing diverse stakeholders involved in the design, funding, conduct, review, and publication of trial protocols.

5 The final products consist of the SPIRIT 2013 Statement and the accompanying Explanation

5 The final products consist of the SPIRIT 2013 Statement and the accompanying Explanation & Elaboration paper, which were published in January 2013. SPIRIT 2013 builds on other applicable international guidance by citing empirical evidence and providing additional recommendations. It adheres to the ethical principles mandated by the 2008 Declaration of Helsinki, and encompasses the protocol items recommended by the International Conference on Harmonisation Good Clinical Practice E 6 guidance.

6 The SPIRIT Group

6 The SPIRIT Group

7 The SPIRIT Statement The recommendations are outlined in a 33 -item checklist and

7 The SPIRIT Statement The recommendations are outlined in a 33 -item checklist and figure. Important details for each checklist item can be found in the Explanation & Elaboration paper, or by browsing the menu on the left in site. The minimum list of items is by no means exhaustive; particular types of trials warrant additional protocol elements.

8 Site address: http: //www. spirit-statement. org/ Paper address: http: //www. spirit-statement. org/spirit-statement/

8 Site address: http: //www. spirit-statement. org/ Paper address: http: //www. spirit-statement. org/spirit-statement/

9 SPIRIT checklist(33 -item) Administrative information(1 -5) Introduction(6 -8) Methods: Participants, interventions, outcomes(9 -15)

9 SPIRIT checklist(33 -item) Administrative information(1 -5) Introduction(6 -8) Methods: Participants, interventions, outcomes(9 -15) Methods: Assignment of interventions, for controlled trial (16 -17) Methods: Data collection, management, analysis(18 -20) Methods: Monitoring(21 -23) Ethics and dissemination(24 -31) Appendices(32 -33)

10 Administrative information(1 -5) 1: Title 2: Trial registration(Registry-data set) 3: Protocol version 4:

10 Administrative information(1 -5) 1: Title 2: Trial registration(Registry-data set) 3: Protocol version 4: Funding 5: Roles and responsibilities(Contributorship -Sponsor contact information-Sponsor and funder-Committees)

1 -Title 11 Descriptive title identifying the study design, population, interventions, and, if applicable,

1 -Title 11 Descriptive title identifying the study design, population, interventions, and, if applicable, trial acronym. Example “A Multi-center, Investigator-blinded, Randomized, 12 -month, Parallel-group, Non-inferiority Study to Compare the Efficacy of 1. 6 to 2. 4 g Asacol. Therapy QD [once daily] Versus Divided Dose (BID) in the Maintenance of Remission of Ulcerative Colitis. ”

12 2 -Trial registration Registry(Trial identifier and registry name. If not yet registered, name

12 2 -Trial registration Registry(Trial identifier and registry name. If not yet registered, name of intended registry). ü When registration in multiple registries is required (e. g. , to meet local regulation), each identifier should be clearly listed in the protocol and each registry. Example Clinical. Trials. gov: NCT 01066572 Data set(All items from the World Health Organization Trial Registration Data Set).

3 -Protocol version 13 Date and version identifier 2004 -Jan-30: Original . . .

3 -Protocol version 13 Date and version identifier 2004 -Jan-30: Original . . . 2004 -Feb-7: Amendment 01. : Primary reason for amendment: Changes in Section 7. 1 regarding composition of comparator placebo Additional changes (these changes in and of themselves would not justify a protocol amendment): Correction of typographical error in Section 3. 3. . . Example Issue Date: 25 Jul 2005 Protocol Amendment Number: 05 Author(s): M. D. ; J. H. Revision Chronology: . . . 2005 -Jul-25: Amendment No. 5: At the request of US FDA [United States Food and Drug Administration] statements were added to the protocol to better clarify and define the algorithm for determining clinical or microbiological failures prior to the follow-up vi

4 -Funding 14 Sources and types of financial, material, and other support. Example “Tranexamic

4 -Funding 14 Sources and types of financial, material, and other support. Example “Tranexamic acid will be manufactured by Pharmacia (Pfizer, Sandwich, UK [United Kingdom]) and placebo by South Devon Healthcare NHS Trust, UK. The treatment packs will be prepared by an independent clinical trial supply company (Brecon Pharmaceuticals Limited, Hereford, UK).

15 5 -Roles and responsibilities Contributor ship(Names, affiliations, and roles of protocol contributors) Sponsor

15 5 -Roles and responsibilities Contributor ship(Names, affiliations, and roles of protocol contributors) Sponsor contact information(name and contact information for the trial sponsor. ) Sponsor and funder(Role of study sponsor and funders, if any, in study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication, including whether they will have ultimate authority over any of these activities) Committees(Composition, roles, and responsibilities of the coordinating centre, steering committee, endpoint adjudication committee, data management team, and other individuals or groups overseeing the trial, if applicable (see Item 21 a for Data Monitoring Committee)

16 Introduction 6 -Background and rationale(Description of research question and justification for undertaking the

16 Introduction 6 -Background and rationale(Description of research question and justification for undertaking the trial, including summary of relevant studies (published and unpublished) examining benefits and harms for each intervention. ) 7 -Objectives(Specific objectives or hypotheses). 8 -Trial design(Description of trial design including type of trial (e. g. , parallel group, crossover, factorial, single group), allocation ratio, and framework (e. g. , superiority, equivalence, non-inferiority, exploratory).

17 Methods: Participants, interventions, outcomes 9 -Study setting(Description of study settings (e. g. ,

17 Methods: Participants, interventions, outcomes 9 -Study setting(Description of study settings (e. g. , community clinic, academic hospital) and list of countries where data will be collected. Reference to where list of study sites can be obtained) 10 -Eligibility criteria(Inclusion and exclusion criteria for participants) 11 -Interventions(Interventions, Modifications, Adherence, Concomitant care) 12 -Outcomes(Primary, secondary, and other outcomes, method of aggregation, time point for each outcome. 13 -Participant timeline(Time schedule of enrolment, interventions (including any runins and washouts), assessments, and visits for participants. 14 -Sample size(estimated number of participants needed to achieve study objectives and how it was determined) 15 -Recruitment(Strategies for achieving adequate participant enrolment to reach target sample size).

18 Methods: Assignment of interventions (for controlled trials) 16 -Allocation( Sequence generation, Concealment mechanism,

18 Methods: Assignment of interventions (for controlled trials) 16 -Allocation( Sequence generation, Concealment mechanism, Implementation) 17 -Blinding (Blinding, Emergency unblinding)

19 Methods: Data collection methods 18 -Data collection methods(Plans for assessment and collection of

19 Methods: Data collection methods 18 -Data collection methods(Plans for assessment and collection of outcome, baseline, and other trial data, including any related processes to promote data quality (e. g. , duplicate measurements, training of assessors) and a description of study instruments (e. g. , questionnaires, laboratory tests) along with their reliability and validity, if known. Reference to where data collection forms can be found, if not in the protocol. Retention(Plans to promote participant retention and complete follow-up, including list of any outcome data to be collected for participants who discontinue or deviate from intervention protocols. 19 -Data management(Plans for data entry, coding, security, and storage). 20: Statistical methods(Outcomes, Additional analyses, Analysis population and missing data)

20 Methods: Monitoring 21 -Data monitoring(Formal committee, Interim analysis) 22 -Harms(Plans for collecting, assessing,

20 Methods: Monitoring 21 -Data monitoring(Formal committee, Interim analysis) 22 -Harms(Plans for collecting, assessing, reporting, and managing solicited and spontaneously reported adverse events and other unintended effects of trial interventions or trial conduct). 23 -Auditing(Frequency and procedures for auditing trial conduct, if any, and whether the process will be independent from investigators and the sponsor.

21 Ethics and dissemination 24 - Research ethics approval(Plans for seeking research ethics committee/institutional

21 Ethics and dissemination 24 - Research ethics approval(Plans for seeking research ethics committee/institutional review board (REC/IRB) approval) 25 -Protocol amendments(Plans for communicating important protocol modifications) 26 - Consent or assent(Who will obtain informed consent or assent from potential trial participants or authorized surrogates, and how ) 27 -Confidentiality(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). 28 -Declaration of interests(Financial and other competing interests for principal investigators for the overall trial and each study site) 29 - Access to data(Statement of who will have access to the final trial dataset, and disclosure of contractual agreements that limit such access for investigators). 30 - Ancillary and post-trial care(Provisions, if any, for ancillary and post-trial care, and for compensation to those who suffer harm from trial participation). 31 -Dissemination policy(Trial results, Authorship, Reproducible research)

22 Appendices 32 -Informed consent materials (Model consent form and other related documentation given

22 Appendices 32 -Informed consent materials (Model consent form and other related documentation given to participants and authorized surrogates) 33 -Biological specimens (Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in the current trial and for future use in ancillary studies, if applicable)

23 figure(Schedule of enrolment, interventions, and assessments)

23 figure(Schedule of enrolment, interventions, and assessments)

24 Citing SPIRIT If referencing the SPIRIT 2013 Statement or Explanation & Elaboration, we

24 Citing SPIRIT If referencing the SPIRIT 2013 Statement or Explanation & Elaboration, we recommend using journal article citations rather than citing the SPIRIT website. Click here for the SPIRIT publications Translations ü Chinese ü Korean ü Spanish

25 Relevant websites

25 Relevant websites

26 Implementation tools SEPTRE (SPIRIT Electronic Protocol Tool & Resource) – Coming soon We

26 Implementation tools SEPTRE (SPIRIT Electronic Protocol Tool & Resource) – Coming soon We are developing a web-based tool to make protocol drafting easier.