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 |
|---|---|---|
| Â | Â | Median (IQR) |
|  |  | or %†|
General information | Â | Â |
 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 | Â | Â |
 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 | Â | Â |
Participants | Â | Â |
 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 | Â | Â |
 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 | Â | Â |
 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 | Â | Â |
 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 | Â | Â |
 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 | Â | Â |
 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 | Â | Â |
 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 | Â | Â |
 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 | Â | Â |
 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 | Â | Â |
 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) |