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) |