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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.