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Table 4 Common concepts requested in the 23 protocol guidelines with explicit methodology or institutional adoption (numbers in parentheses represent number of guidelines)*

From: Guidelines for randomized clinical trial protocol content: a systematic review

Concepts in >75% guidelines  
General Statistical analysis
  Rationale/purpose (20)   Statistical/analysis methods (general) (21)
  Objectives (general) (18)  
Concepts in 51-75% of guidelines  
General Recruitment and eligibility (continued)
  Trial sites/institutions/ location (12)   Sample size + sample size/power calculation (17)
  Background (general) (14) Treatments and allocation
Design   Treatment/interventions (general) (14)
  Study design type/description (17) Assessments
Recruitment and eligibility   Outcomes/ endpoints (list) (15)
  Eligibility criteria (16)  
Concepts in 26-50% of guidelines  
General Statistical analysis
  Protocol/study title (9)   Interim analysis description/general methods (7)
  Principal investigator - name and address (9)   Trial termination criteria/stopping rules (6)
  Protocol summary (6) Safety and monitoring
  Prior research (literature review) (10)   Assessment of safety - general (7)
  Summary of known potential risks/benefits (6)   Safety monitoring/procedures for unscheduled  events (9)
Design   SAE reporting procedures (to sponsor and regulatory
  Statistical hypotheses (8)   authorities) (8)
  Study schematic/flow-chart (for example, periods, duration) (6)   Data monitoring committee (role, composition, independence) (7)
  Source population/recruitment source (7)   Data management/record keeping (general) (9)
Recruitment and eligibility   Methods to ensure data quality/integrity (for example, monitoring, validation) (7)
  Recruitment methods/subject selection (11) Ethical considerations
  Information for patients and consent/methods (8)   Ethics (general heading) (6)
  Eligible concomitant therapies (6)   IRB review/approval/responsible IRBs (7)
  Subject drop-out criteria (7) Dissemination
  Justification for sample size calculation (6)   Publication policy (general) (6)
Treatments and allocation   Disseminating results/publication plan (general) (7)
  Description of treatment (10) or comparators (8) Other
  Treatment duration (8)   Trial management (general - personnel and administration) (9)
  Allocation/randomization methods (general) (10)   Budget (6)
  Degree of blind (for example, double, who)/blinding methods (8)   References/cited literature (10)
Assessments   Appendices (general) (6)
  General (variables and data collection) (10)   Copy of all questionnaires and data forms (8)
  Primary endpoint(s)(7), Secondary endpoint(s) (6) (list)  
  Methods of assessment/required tests (11)  
  Timing of outcome assessment (7)  
  Follow-up procedures (7)  
Concepts in ≤ 25% of guidelines (n = 333; subset provided below)  
General Treatments and allocation (continued)
  Site investigators/collaborators - names and addresses (4)   Reasons for degree of blinding (3)
  Sponsor - name and address (5) Assessments
  Registration plans/registration number (4)   Assessment of compliance (5)
  Protocol identifying number (5)   Validity/reliability of collection/measurements (1)
  Funding source (3) Statistical analysis
  Rationale with reference to a systematic review (3)   Description of planned subgroup analyses (2)
Recruitment and eligibility Other
  Target population (5)   Participant security/confidentiality (5)
  Justification for special (for example, vulnerable) pop. (5)   Study timetable (calendar (date) of events) (5)
  Specific eligibility criteria - for example, health status  (2), co-enrolment in trials (2)   Target duration for trial as a whole (5)
Treatments and allocation   Approximate time to complete enrolment (5)
  Treatment dosage (5), route of admin. (5), justification (5)   Dummy tables (3)
  Form and location of treatment code (5)   Curriculum vitae of investigators (5)
  Allocation concealment (3), Implementation of randomization (1)   Incentive to investigators/staff (1), participants (2)
     Conflict of interest (1)
    Consumer involvement (who and roles) (1)