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Table 3 Concepts of ‘moderate’ or ‘low’ 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 %†
Rated ‘moderate’ importance   
Protocol summary B Use of lay/non-technical language I = 63; E = 27; U = 10
List of abbreviations List and descriptors of abbreviations used in protocol I = 74; E = 19; U = 8
Eligibility criteria B Justification of exclusion of subgroups I = 66; E = 28; U =6
Monetary/materials support B List the type(s) of support provided I = 70; E = 21; U = 10
Feasibility§ Acceptability for personnel/participants; capacity for recruitment 6 (3,8)
Co-enrolment in studies§ Regulations pertaining to co-enrolment in other research studies 7 (5,8)
Investigational product(s)§ Formulation, packaging, labeling and supply; accountability 7 (5,9)
Pregnancy§ Monitoring of health of woman and child (short and long term) 7 (4,10)
Ancillary and substudies§ Foreseen future uses of data or biological materials; consent 7 (5,9)
Post-trial data/materials storage§ Data/materials storage: location(s), duration, responsibility 7 (4,8)
Appendix materials A Samples of the standardized case-report forms I = 65; E = 23; U = 12
Appendix materials B Other data collection forms (for example questionnaires) I = 70; E = 21; U = 10
Appendix materials C Consent/assent forms I = 72; E = 23; U = 5
Rated ‘low importance’   
General approach Outline the general approach to address the research question I = 52; E = 42; U = 6
Study locations B Briefly justify sites(s) where research is to be conducted I = 46; E = 46; U = 8
Study locations C Relevant demographic/epidemiological information of study region I = 46; E = 47; U = 8
Study timeline B Schematic of the study stages’ expected completion dates I = 58; E = 30; U = 12
Withdrawals C In a multicentre study, when a centre may be discontinued I = 55; E = 30; U = 16
Monetary/materials support C The amount of support provided I = 30; E = 57; U = 13
Monetary/materials support D How support is provided (for example research account, honorarium) I = 35; E = 53; U = 12
Personnel Names, affiliations, contact details of key trial personnel I = 40; E = 51; U = 9
Logistics Availability of resources incl. administration, equipment, facilities I = 27; E = 64; U = 10
Budget Budget for personnel, equipment, facilities and supplies 5 (2,6)
Signatures§ Signatures including principle investigators or chief medical officer 5 (2,8)
Insurance§ Plans including coverage to provide treatment and compensation 5 (2,7)
  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. ‡Items requiring additional clarification or subconcepts of original items which required delineation in Round 3. §Concepts added by panellists in Round 1 for rating in Round 2 and 3.