Skip to main content

Table 2 Consensus - concepts of ‘high importance’ for minimum protocol content following two or three survey rounds

From: Developing a guideline for clinical trial protocol content: Delphi consensus survey

Section and topic Brief description* Results
   Median (IQR)
   or %†
General information   
 Title Descriptive title identifying study design 10 (9,10)
 Trial identifier Unique number/name and registration information 10 (9,10)
 Protocol version Version or amendment number and date 10 (8,10)
 Protocol summary A Short summary of proposed research I = 94; E = 5; U = 1
 Names and addresses Names/addresses of primary investigators and sponsor 10 (8,10)
 Table of contents List of contents and page numbers 8 (5,9)
Introduction   
 Rationale Outline topic and provide justification for study 10 (9.5, 10)
 Background of the study Summary of all previous studies (that is, a SR or reference) 10 (9,10)
 Preliminary data Describe preliminary studies (for example by investigators) 9 (8,10)
 Objectives Specific objectives and hypotheses for the study 10 (10,10)
 Study location(s) A Description of intended sites(s) I = 87; E = 11; U = 2
Methods   
Participants   
 Population Target and study population and source of the latter 10 (9,10)
 Eligibility criteria A Description of inclusion and exclusion criteria (participants) I = 99; E = 1; U = 0
 Sample size Estimated number; calculations and assumptions 10 (10,10)
 Recruitment Process of recruitment (for example advertisements) and enrolment 9 (8,10)
Design   
 Type of study Description of type/design and trial framework (for example superiority) 10 (10,10)
 Study timeline A Diagram of participants’ procedures and visits through trial stages I = 84; E = 10; U = 6
 Sequence generation Method used to generate random sequence; details of any restriction 10 (9,10)
 Allocation concealment Method used to implement random sequence and whether concealed 10 (10,10)
 Random implementation Who will generate sequence, enrol participants and assign to groups 10 (8,10)
 Blinding Who (for example participants/investigators/outcome assessors) 10 (10,10)
Interventions   
 Interventions A Precise details; how they will be administered (for example dosage, form) I = 99; E = 1; U = 0
 Interventions B Justification of control I = 87; E = 8; U = 5
 Schedule of interventions Number and duration of treatment periods including run-in, washout 10 (10,10)
 Concomitant interventions List of relevant treatments permitted or not before or during trial 10 (9,10)
 Risks/Harms Known or potential risks for each study intervention 10 (10,10)
Data collection / management   
 Outcomes Describe and define primary and secondary outcomes 10 (10,10)
 Data collection Methods, instruments and timing of data collection and recording 10 (9,10)
 Biological specimens§ Laboratory evaluation, specimen collection, storage and shipping 8 (6,9)
 Validation of instruments§ Reliability/validity of instruments or plans to establish validation 8 (6,9)
 Follow-up Plans including description and schedule of visits and logistics 10 (9,10)
 Data management Plans for data entry, editing, coding and storage 8 (7,9)
 Quality control Methods for quality of outcome assessment and data records 9 (8,10)
 Compliance Procedures and measures to monitor participant compliance 9 (8,10)
Statistical methods   
 Statistical methods Methods for primary/secondary outcomes and additional analyses 10 (10,10)
 Withdrawals A Criteria to withdraw or exclude participants from the intervention I = 95; E = 2; U = 2
 Withdrawals B Data to be collected from, and follow-up of, withdrawn participants I = 85; E = 5; U = 10
 Missing data Methods to account for missing or erroneous data 9 (8,10)
 Interim trial monitoring Process and timing of any planned interim analyses 10 (9,10)
 Stopping guidelines A Predefined statistical stopping boundaries I = 92; E = 6; U = 2
 Stopping guidelines B Non-statistical criteria for the early trial termination I = 76;E = 12;U = 12
Safety and monitoring   
 Safety evaluations Plans for monitoring safety including methods and timing. 10 (9,10)
 DSMB If relevant, composition and role of DSMB 9 (9,10)
 Adverse event reporting Methods of recording/reporting events; methods to deal with them 10 (9,10)
 Emergency code-breaking Establishment/storage of code; when and by whom it can be broken 10 (8,10)
 Trial monitoring§ Plans and frequency including if independent 8 (6,9)
Trial organization/administration   
 Monetary/material support A Source(s) of financial and material support I = 94; E = 5; U = 1
 Data ownership§ Who has ownership; contractual limits for principal investigators 8 (7,10)
Ethical considerations   
 Potential benefits and risks Potential benefits and risks to participants and society 10 (9,10)
 Agreement and consent Method and person responsible; materials for potential participants 10 (9,10)
 Surrogate consent/assent Method of obtaining surrogate consent or assent 10 (9,10)
 Confidentiality/Anonymity Provisions for protecting personal data and privacy of participants 10 (9,10)
 Ethics approval Whether it has been obtained and name of committees 10 (8,10)
 Role of sponsor Role of sponsor in design, data collection, analysis, dissemination 10 (8,10)
 Conflict of interest Financial or other real or perceived conflicts of interest 10 (8,10)
 Post-trial care§ Post-trial follow-up, access to treatment, duration; who is responsible 8 (6,9)
Reporting and dissemination   
 Protocol amendments Methods of communicating to investigators/IRBs and documenting 9 (7,10)
 Dissemination How results will be disseminated to participants, practitioners, public 8 (7,10)
 Publication policy Who has right to publish; restrictions; authorship guidelines 9 (7,10)
 Reporting of early stopping§ Dissemination of results if trial is stopped early (for any reason) 8 (5,10)
Other   
 Limitations Limitations of proposed study, including risk of bias 8 (6,10)
 References List of references cited in protocol 10 (9,10)
 Data collection forms§ Summary table of all forms to be collected at each time point 8 (6,9)
  1. *Abbreviated version of the full description provided to panellists. †Final results from Round 2 or 3; presented as median (IQR) or % Include (I); % Exclude (E); % Unsure (U), as relevant. ‡Subconcepts of original items which required delineation in Round 3. §Concepts added by panellists in Round 1 for rating in Round 2 and 3. DSMB, Data and Safety Monitoring Board; SR, systematic review.