This document summarizes a journal club presentation on the SPIRIT 2013 statement, which provides a 33-item checklist for clinical trial protocols. The presentation discusses the development of the SPIRIT initiative by over 100 contributors from various stakeholder groups using a Delphi consensus process and systematic reviews. The SPIRIT checklist aims to improve the transparency and completeness of trial protocols. Key items on the checklist include the background and rationale, trial objectives, eligibility criteria, interventions, outcomes, sample size calculation, and plans for participant recruitment, allocation, blinding, and statistical methods.

1. Journal Club 22/3/2013
Pawin Numthavaj, M.D.
2008th year Ph.D. student
Section of Clinical Epidemiology
Faculty of Medicine Ramathibodi Hospital
Mahidol University

2. Introduction
• Protocol — document that details
• Study rationale
• Proposed methods
• Organization
• Ethical considerations
• “Plan” for study conduction at all stages

3. Introduction
• Diverse stakeholders
• Funding agency
• Ethic committees
• Institutional review boards
• Regulatory agencies
• Medical journals
• Systematic reviewer, etc.
• Protocols should adequately address key trial elements
• International groups of stakeholders launched SPIRIT

4. SPIRIT
• Standard Protocol Items: Recommendations for Intervention Trials
• Initiative started in 2007
• Main output is SPIRIT 2013 statement
• 33 items checklist
• SPIRIT 2013 explanation and elaboration documents

5. SPIRIT
• 115 contributors
• Trial investigators
• Healthcare professionals
• Methodologists
• Statisticians
• Trial coordinators
• Journal editors
• Representatives from ethic committees
• Representatives from industry and non-industry funders
• Regulatory agencies
• Three complimentary methods
• Delphi consensus survey
• Two systematic reviews to identify existing protocol guidelines
• Two face-to-face consensus meetings to finalize the checklist

6. Experts
Provide opinions or the
team select suitable
expert to participate in
subsequent rounds
Rank their agreement
& Summarize by research team
± rate their opinion confidence
Re-rank their agreement with
opportunity to change scores in
view of group’s response

7. Intention of SPIRIT
• Intended as a guide for those preparing a full protocol for clinical trial
• Transparent and complete description of what is intended
• If information for a recommended item is not yet available (e.g., funding
sources) this should be explicitly stated, and the protocol updated as
new information is obtained

8. Availability
• Published in key medical journals
• Available with additional
examples at www.spirit-
statement.org

9. Administrative Information
1. Descriptive title identifying the study design,
population, intervention, and, if applicable, trial
acronym
• Succinct description that conveys
• Topic (Study population, interventions)
• Acronym (If any)
• Basic study design Ex. Allocation (Parallel group randomized controlled trials;
single group trial)
• Helpful to include
• Framework (superiority/inferiority)
• Objective/primary outcome
• Study phase (phase III)

10. Trial registration - registry
2a.Trial identifier and registry name. If not yet registered,
name of intended registry.
• Increased transparency
• Decrease duplication of research effort
• Facilitate identification of ongoing trials for prospective participants
• Identify selective reporting of result
• Registration should occur before recruitment of first participant

11. Trial registration - dataset
2b. All items from the World Health Organization trial
registration data set
• Minimum standard list of items to be included in a trial registry in order
for a trial to be considered fully registered
• http://www.who.int/ictrp/network/trds/en/index.html
• Serves as brief structured summary of the trial

14. Protocol version
3. Date and version identifier
• Helps to mitigate potential confusions over which document is most
recent
• Explicitly listing of changes relative to previous version is also important

15. Funding
4. Sources and types of financial, material, and other
support
• Relevant information to assess study feasibility and potential competing
interests
• Industry funded are more likely to report trial results and conclusions
that favor their own interventions
• Select effective intervention for evaluation
• Less effective control
• Selective report outcomes, analysis, or full study
• Minimum
• Sources of financial and non-financial support
• Specific type (eg, funds, equipment, drugs, services) and time period
• If not yet supported, detail proposed sources

16. Roles and responsibilities - contributorship
5a.Names, affiliations, and roles of protocol contributors
• Provide due recognition, accountability, and transparency
• Help to identify competing interests and ghost authorship
• Ghost authorship occurs when an individual makes a substantial contribution to
the research but is not listed as an author.
• Also a standard for protocols published in journals such as Trials

17. Roles and responsibilities sponsor contact information
5b.Name and contact information for trial sponsor
• Sponsor: individual, company, institution, or organization assuming
overall responsibility for the initiation and management of the trial
• Not necessarily the main funder
• Provides transparency and accountability

18. Roles and responsibility sponsor and funder
5c. Role of study sponsor and funders in study design; collection,
management, analysis, and interpretation of data; writing of
the report; and the decision to submit for publication
• Explicitly outline roles and responsibilities of sponsor and any funders in
• Study design
• Conduct
• Data analysis and interpretation
• Manuscript writing
• Dissemination of results

19. Roles and responsibilities committees
5d.Composition, roles and responsibilities of the
coordinating center, steering committee, endpoint
adjudication committee, and data management team
• Outline general membership of various committees or groups involved in
trial coordination and conduct
• Roles and responsibilities

20. Introduction: Background and rationale
6a.Description of research question and justification,
summary of relevant studies examining benefits and
harms
• Summarize the importance of the research question
• Justify the need for the trial in the context of available evidences
• Strongly recommended that an up-to-date systematic review of
relevant studies be summarized and cited in the protocol
• Failure to do so leads to unnecessary research and exposes participants
to possible harms

21. Background and rationale choice of comparators
6b.Explanation for choice of comparators
• Clear description of the rationale for the comparator intervention
• Standard treatment in that condition
• Ex: inappropriately low dose of active drug in control will overestimate
the relative efficacy of study intervention in real practice

22. Objectives
7. Specific objectives or hypotheses
• Reflect the scientific question to be answered
• Generally phrased using neutral wording rather than particular direction
of effect
• For multi-arm trials, clarify the way the way in which all the treatment
groups will be compared (eg, A vs B; A vs C), in what outcome

23. Trial design
8. Description of trial design including type of trial,
allocation ratio, and framework
• Types: parallel group, crossover, factorial, single group
• Framework: superiority, equivalence, non-inferiority, exploratory
• Most common design: parallel group, two-arm, superiority trial with 1:1
allocation ratio.

24. Methods participant
9. Description of study settings and list of countries where
data will be collected
• At minimum:
• Countries
• Types of setting (urban/rural/hospital/community-based)
• Likely number of study sites

25. Eligibility criteria
10.Inclusion and exclusion criteria for participants,
eligibility criteria for study centers and individuals who
perform intervention (surgeon)
• Define the study population
• Eligibility for care provider
• Promote consistency of intervention
• Clear description of eligibility criteria
• Enables study personnel to apply these criteria consistently throughout the trial
• Convey key information related to external validity (generalizability)

27. Interventions
11a. Interventions for each group with sufficient detail to
allow replication (including how and when)
• Drugs/biological agents/placebos • Non-drug
• Generic name • Details about setting (Item 9)
• Manufacturer • Details of individuals administering
• Constituent components intervention (pre-trial expertise,
• Route of administration specific training)
• Dosing schedule (including titration
and run-in periods if applicable)

29. Interventions modifications
11b. Criteria for discontinuing or modifying allocated
interventions for given trial participants
• Define standard criteria for intervention modifications and
discontinuations
• Study participants should be retained in the trial whenever possible to
enable follow-up data collection and prevent missing data

31. Interventions adherence
11c. Strategies to improve adherence to intervention
protocols and procedures to monitor adherence
• Low adherence: effect on statistical power and interpretation of trial
result
• Description of procedures and strategies for monitoring and improving
adherence

32. Interventions concomitant care
11d. Concomitant care & interventions permitted or
prohibited during the trial
• Co-intervention bias: when study groups receive different
care/intervention (in addition to assigned trial intervention) that may
affect outcomes
• Protocol should list concomitant care and interventions that are
allowed, including rescue intervention

33. Outcomes
12. Primary, secondary, other outcomes
• Protocols should define four components for each outcome
1. Specific measurement variables (e.g. systolic BP)
2. Specific measurement time point of interest for analysis
3. Analysis metric (e.g. change from baseline, final value, actual value changes
over time, time to event)
4. Method of aggregation (mean ( median), proportion , rate)
• Explain the rationale
• Number of primary outcomes should be as small as possible
• Problems of multiplicity, selective reporting, and interpretation when there are
inconsistent results among outcomes

34. 12. Primary, secondary, other outcomes (continued)
• Development of common set of key outcomes within a specialty can
help to deter selective reporting & facilitate comparisons and pooling in
meta-analysis
• COMET (Core Outcome Measures in Effectiveness Trials) initiatives
facilitate development and application of such standardized sets
• www.comet-initiative.org

36. Participant timeline
13. Time schedule of enrolment, interventions, assessments,
and visits for participants. Schematic diagram highly
recommended
• Clear and concise timeline helps guide trial conduct and enables
external review of burden and feasibility
• Key information
• Timing of each visit
• Time periods during which trial interventions will be administered
• Procedures and assessments performed at each visit

38. Sample size
14. Estimated number of participants needed to achieve
study objectives and how it was determined
• If sample size is not derived statistically, then this should be explicitly
stated along with rationale (exploratory pilot studies; pragmatic
consideration for rare diseases)
• Calculation based on one primary outcome
• Also worthwhile calculating power that will be available for other outcomes

39. Report
• Outcomes
• Value assumed for outcome in each group particularly in comparators
with citation
• Statistical test
• Alpha (Type I error) level
• Power
• Calculated sample size per group

41. Recruitment
15. Strategies for achieving adequate participant
enrolment to reach target sample size
• Description of where participants will be recruited (clinic, community),
by who, and how (advertisement, review of health records)
• Expected recruitment rates
• Duration of recruitment periods
• Plans to monitor recruitment
• Financial/nonfinancial incentives provided to trial
investigators/participants

42. Allocation-sequence generation
16a. Method of generating the allocation sequence and list
of any factors for stratification.
• Randomization:
• Decrease selection bias in allocation
• Help blinding
• Enable the use of probability theory to test the difference in outcome between
groups
• Use of "randomization" term without further elaboration is not
sufficient
• If non-random allocation is planned, specific method and rationale
should be stated.

43. Key elements of random sequence to
specify
• Method of sequence generation (random number table/generator)
• Allocation ratio
• Type of randomization and reason
• Factors used for stratification

44. Randomization Types
• Simple randomization
• Restricted randomization
• Block randomization
• Biased coin and urn randomization
• Stratified randomization
• Minimisation

45. Simple randomization
• Based on single, constant allocation ratio
• 1:1 allocation – analogous to coin toss
• No other allocation approach surpasses
the bias prevention and unpredictability of
simple randomization

46. Restricted randomization
• Any randomization approach that is not simple randomization
• Blocked randomization (permuted block randomization)
• Assures that study groups of approximately the same size will be generated
when an allocation of 1:1 is used
• Ensures close balance of groups at any time during the trial
• Reducing the unpredictability of the sequence
• Blinding, larger block size, randomly varying block size will reduce this problem

47. Restricted randomization
• Stratified randomization
• Ensured good balance of participant characteristics in each group
• Separate randomization within each of two or more strata of participants (e.g.,
categories of age)
• Requires some form of restriction (e.g., blocking within strata)
• Number of strata should be limited to avoid over-stratification
• Example: Stratified by center in multicenter trial
• Biased coin and urn randomization
• Attain similar objective as blocked design without forcing strict equality
• Alter the allocation ratio during the course of the trial to rectify imbalances that
might be occurring
• Urn randomization: varying allocation ratios based on the magnitude of the
imbalance

48. Biased Coin
• Altering allocation probability during the
course of the trial to rectify balances in
group numbers
• Example:
• start with 0.5 / 0.5 probability
• If the disparity reaches the limit the
probability change to : 0.6 / 0.4

49. Urn Randomization
• Adaptive biased-coin
• UD (α,β) – UD (2,1)
• Urn contained 2 (α) blue balls and 2 green balls
(0.5 / 0.5 probability)
• Drawn ball at random
• Replace ball with two balls (one blue, one green)
and one (β) additional ball of opposite color
• Change in probability during each assignment

50. Restricted randomization
• Minimization
• Assures similar distribution of selected participant factors between study groups
• Randomization lists are not set up in advance
• First participant is truly randomly allocated
• Subsequent participant: treatment allocation that minimizes the imbalance on
the selected factors between group at the time
• Advantage: making small groups closely similar in terms of participant
characteristics at all stages of trial
• Some methodologists considered superior to randomization
• For SPIRIT, minimization is considered a restricted randomization

51. Need for separate document to describe
restricted randomization
• If some type of restricted randomization is to be used (blocked /
minimization) the knowledge of specific details could lead to bias
• If block size is 6, trial implementers know that if two As and three Bs have
already been done, they will know the next one
• This is a problem in both open label and ineffectively blinded trials
• Do not provide the full details of a restricted randomization scheme
(including minimization) in the trial protocol
• Simple randomization procedures should be reported in detail because
simple randomization is totally unpredictable

52. Allocation concealment mechanism
16b. Mechanism of implementing the allocation sequence
(e.g., telephone; envelopes), describing any steps to
conceal the sequence
• Concealment aims to prevent participants and recruiters from knowing
the study group to which the next participant will be assigned
• Common practice: enclose assignments in sequentially numbered,
sealed, opaque envelopes

54. Allocation implementation
16c. Who will generate sequence, who will enroll
participants, and who will assign participants to
intervention
• Complete separation of 2 groups of individuals
1. Involved in steps before enrolment (sequence generation, allocation
concealment)
2. Involved in implementation of study group assignments
• Specify
• Who will implement randomization process
• How and where allocation list will be stored
• Mechanisms to minimize possibility that those enrolling individuals have access
to list

55. Blinding (Masking)
17a. Who will be blinded after assignment to interventions
and how
• Awareness of intervention can introduce:
• Ascertainment bias (different outcome measurements)
• Performance bias (decision to discontinue/modify intervention)
• Concomitant intervention
• Exclusion/attrition bias (decision to withdraw/exclude from analysis)
• When blinding is not possible (obvious differences in interventions):
• Blind outcome assessors
• Blind hypothesis in terms of which intervention is considered active

56. • Description of who is blinded is preferred over ambiguous terminology
such as “double blind”
• Trial participants
• Care providers
• Data collectors
• Outcome assessors
• Data analysts
• Manuscript writers
• Describe the comparability of blinded intervention
• Appearance
• Flavor/taste
• Timing of final unblinding (e.g. after the creation of a locked analysis data set)

57. • Strategies to reduce potential for unblinding
• Pre-trial testing of blinding procedures
• Use unique code for each participants rather than fixed code (A=Group1,
B=Group2)
• Unblinding of one participant will result in the loss of blinding for all participants

58. Blinding (Masking) emergency unblinding
17b. Circumstances under which unblinding is permissible
intervention during the trial
• Emergency unblinding intended to increase the safety of trial
participants
• Clear description of emergency unblinding
• Prevent unnecessary unblinding
• Facilitates implementation
• Enables evaluation of appropriateness of planned procedures

59. Methods data collection, management, and analysis
18a. Plans for assessment and collection of outcome,
baseline, and other trial data
• Related process to promote data quality
• Duplicate measurement, training of assessors
• Description of study instruments
• Questionnaire, laboratory tests
• Reliability and validity of instruments
• Where data collection form can be found if not in the protocol

60. • Validity and reliability of trial data depends on quality of data collection
• Avoid
• Modified versions of validated measurement tools: no longer be considered
validated
• Unpublished measurement scales
• Standard process should be implemented by local study personnel to
enhance data quality and reduce bias
• Inclusion of data collection forms in the protocol (i.e., as appendices) is
highly recommended

61. Data collection method retention
18b. Plans to promote retention and complete follow-up,
list of any outcome data to be collected for those who
discontinue or deviate from protocols
• Non-retention: participants are prematurely “off study”
• Consent withdrawn
• Lost to follow-up
• Plan for how to promote retention in order to prevent missing data
• Methods:
• Financial reimbursement
• Systematic methods and reminders for contacting patients
• Scheduling appointments
• Monitoring retention
• Limiting burden related to follow-up visits and procedures

62. • Non-adherence: deviation from intervention protocol
• Does not mean “off study”
• Should not be reason for ceasing to collect data
• All participants be included in an intention-to-treat analysis, regardless
of adherence
• Describe
• Retention strategies
• What to record from non-adherence participants
• Plan to record reasons for non-adherence and non-retention

63. Data Management
19. Plans for data entry, coding, security, and storage,
including process to promote quality (double entry,
range checks)
• Full description of data entry and coding process
• Measures to promote data quality
• Document data security measures to prevent unauthorized access
• Plans for data storage during and after trial
• Standard coding practice for non-numeric data to reduce errors and
observer variations

64. Data entry
• Local data entry
• Fast correction of missing/inaccurate data
• Central data entry (in paper forms)
• Facilitates blinding
• Standardization
• Training of a core group of data entry
personnel

65. Data entry
• Standard process to improve accuracy of data entry and coding
• Verification of proper format (integer)
• Expected range check
• Double data entry (but weigh time and costs against the magnitude of reduction
in error rates)

66. Statistical methods
• Should be fully described in the protocol
• If certain aspects cannot be pre-
specified (e.g. method of examining
pattern of missing data) then outline
planned approach to making final
choice
• May have a separate document:
statistical analysis plan (SAP)

67. Statistical methods outcomes
20a. Statistical methods for analyzing primary and
secondary outcomes
• Indicate explicitly each intended analysis comparing study groups
• Pre-specify main (“primary”) analysis of the primary outcome
• Analysis methods to be used
• Which trial participants will be included
• How missing data will be handled
• Helpful to indicate effect measure (e.g., relative risk) and significance level that
will be used, as well as intended use of confidence intervals

68. • Specify which comparisons (one or more study groups) will be
performed, and which will be the main comparison of interest
• Reduce risk of false positives (type I) when multiple statistical comparisons are
performed
• Different trial designs dictate most appropriate plans and additional
relevant information
• Cluster, factorial, crossover, within-person trial requires specific statistical
consideration

69. Statistical methods additional analyses
20b. Methods for any additional analyses (e.g., subgroup
and adjusted analysis)
• Subgroup analysis
• Often selectively reported or not specified
• Post hoc analyses: high risk of spurious findings and are discouraged
• Preplanned subgroup analysis should be clearly specified
• Definition of categories
• Statistical method
• Hypothesized direction of subgroup effect based on plausibility

70. • Adjusted analysis
• Indicate if there is intention to perform or consider adjusted analyses
• Explicitly specifying any variables for adjustment and how variables will be
handled
• If it is not clear which variable will be important for adjustment, objective
criteria to be used to select variables should be pre-specified

71. Statistical methods analysis population and missing data
20c. Definition of analysis population relating to protocol
non-adherence and statistical methods to handle
missing data
• Intention to treat (ITT) analysis
• “as randomized” analysis retains participants in the group which they were
originally allocated
• Included outcome data obtained from all participants regardless of protocol
adherence
• Modification of ITT can introduce bias
• Particularly if the frequency of and reasons for non-adherence vary between
groups

73. • Explicitly describe which participants will be included in the main
analysis (e.g., all randomized participants, regardless of protocol
adherence)
• Avoid ambiguous use of labels such as “intention to treat” or “per
protocol” unless they are fully defined in protocol
• Most analyses labelled as such do not actually adhere to the definition

74. Missing Data Strategies
• Address how missing data will be handled and planned methods to
impute (estimate) missing data
• Methods of multiple imputation are more complex, but preferred to
single imputation (e.g., last observation carried forward)
• Sensitivity analyses are highly recommended to assess the robustness of
trial results under different methods of handling missing data

75. Data monitoring formal committee
21a. Composition of data monitoring committee (DMC),
roles and reporting structure; whether it is independent
from sponsor and competing interests
• Primary role of DMC:
• Periodically review accumulating data
• Determine if a trial should be modified or discontinued
• Does not usually have executive power, but with trial steering
committee or sponsor
• Independent from sponsor and investigators
• Required to declare any competing interests

76. Details of DMC
• Name of the chair and members of DMC
• If members are not yet known: intended size and characteristics
• DMC’s roles and responsibilities
• Planned method of functioning
• Degree of independence from those conducting, sponsoring, or funding
the trial

77. Data monitoring interim analysis
21b. Description of any interim analyses and stopping
guidelines; who will have access to interim results and
make the final decision to terminate the trial
• Result of interim analyses can be part of stopping guideline (stop for
benefit, harm, or futility)
• Can also be used for other trial adaptations
• Sample size re-estimation
• Alteration to proportion of participants allocated to each study group
• Changes to eligibility criteria
• Complete description of interim analysis plan should be provided,
including statistical methods, who will perform, and when

78. State:
• Who will see the outcome data while the trial is ongoing
• Whether these individuals will remain blinded to study groups
• How the integrity of the trial implementation will be protected
• Who has the ultimate authority to stop or modify the trial
• Principal investigator
• Trial steering committee
• Sponsor

79. Harms
22. Plans for collecting, assessing, reporting, and managing
reported adverse events and other unintended effects of
interventions
• Adverse event: untoward occurrence during the trial, may or may not
related to intervention
• Symptoms, signs, laboratory values, or health condition
• Adverse effect: type of adverse event that can be attributed to
intervention
• Distinction should be made between anticipated/unanticipated,
solicited/unsolicited harms

80. • Describe procedures for and frequency of harms data collection
• Overall surveillance timeframe
• Instruments to be used and their validity and reliability
• Plans for data analysis of adverse events
• Address the reporting of harms to relevant groups (sponsor, ethics
committee, DMC, regulatory agency)

81. Auditing
23. Frequency and procedures for auditing trial conduct
and whether the process will be independent from
investigators and the sponsor
• Auditing: periodic independent review of core trial processes and
documents
• Multicenter trials
• Exploring trial dataset
• Performing site visits
• Can be initially conducted across all sites and subsequently conducted using
risk-based approaches (e.g., on sites with highest enrollment rates, large number
of withdrawals, or atypical numbers of reported adverse events)

82. Research ethics approval
24. Plans for seeking research ethics committee /
institutional review board approval
• Document where approval has been obtained, or outline plans to seek
such approval

83. Protocol amendments
25. Plans for communicating important protocol
modifications to relevant parties
• Substantive protocol amendments be reviewed by independent parties
such as REC/IRB and transparently described in trial reports
• Describe process of making amendments
• Who will be responsible for the decision to amend
• How changes will be communicated to relevant stakeholders (e.g., IRB,
regulatory agencies)

84. Consent or assent
26a. Who will obtain informed consent or assent and how
• Model consent or assent form should be provided as a protocol
appendix
• Assent – minor’s affirmative agreement to participate in the trial
• Signing a document that provides age appropriate information about the study
• Details of consent process
• Details of status, experience, and training of team members who will
conduct it
• Cluster randomized trials – may not be possible to obtain consent
before randomization – explanation should be provided in the protocol

85. Consent or assent ancillary studies
26b. Additional consent provisions for collection and use of
participant data and biological specimens in ancillary
studies
• Ancillary studies – additional processes and considerations relating to
consent
• Should be detailed in the protocol
• Options to consider consent for
• Use of data and specimens in specified protocol
• Use in future research unrelated to clinical condition under study
• Submission to an unrelated bio-repository
• Contact by investigators for further information and consent-related purposes

86. Confidentiality
27. How personal information will be collected, shared,
and maintained in order to protect confidentiality
before, during, and after trial
• Describe means whereby personal information is collected, kept secure,
and maintained
1. Creation of coded depersonalized data
2. Secure maintenance of data and linking code in separate locations
(encrypted digital files, password protected folders and storage media)
3. Limiting access to minimum number of individuals necessary for
quality control, audit, and analysis

87. Declaration of interests
28. Financial and other competing interests for principal
investigators
• Financial: • Nonfinancial:
• Salary support/grants • Academic commitments
• Ownership of stocks or options • Personal/professional relationships
• Honorariums (for advice, authorship, • Political, religious, other affiliations
or public speaking) with special interests or advocacy
• Paid consultancy or service on positions
advisory boards
• Receipt of patents or patents
pending

88. Access to data
29. Who will have access to the final trial dataset, and
disclosure of contractual agreements that limit such
access for investigators
• Identify the individuals involved in the trial who will have access to full
dataset
• Restriction in access for trial investigators should also be explicitly
described

89. Ancillary and post-trial care
30. Provisions for ancillary and post-trial care and for
compensation to those who suffer harm from
participation
• Declaration of Helsinki:
• “Protocol should describe arrangements for post-study access by study
participants to interventions identified as beneficial in the study or access to
other appropriate care or benefits”
• Describe plans to provide/pay for ancillary care during the trial
• Identify any intervention, benefits, or other care that sponsor will
continue to provide to participants and host communities after the trial
• Plans to compensate participants from trial-related harms

90. Dissemination policy trial results
31a. Plan to communicate trial results to participants,
healthcare professionals, public, and other relevant
groups, including publication restriction
• Plan to disseminate results to key stakeholders, including process and
timeframe for approving and submitting reports
• Explicit statement that results will be disseminated regardless of the
magnitude or direction of effect
• Publication restriction should be disclosed in the protocol for review by
REC/IRBs, funders, and other stakeholders

91. Dissemination policy authorship
31b. Authorship eligibility guidelines and any intended use
of professional writers
• Individual who fulfil authorship criteria should not be hidden (ghost
authorship)
• Those who do not fulfil criteria should not be granted authorship (guest
authorship)
• Professional medical writers are sometimes hired to improve clarity and
structure in a trial report
• Plans for employment of writer and their funding source both in protocol and
trial reports

92. Dissemination policy reproducible research
31c. Plans for granting public access to the full protocol,
participant level dataset, and statistical codes
• Indicate whether the trial protocol, full study report, anonymized
participant level dataset, and statistical code will be made publicly
available

93. Appendix: Informed consent materials
32. Model consent form and other related documentation
given to participants and authorized surrogates
• Several different consent documents may also be needed
• Pediatric trial:
• Parental permission
• Participant assent documents
• Multicenter trial: revised consent complied with local requirements

94. Biological specimens
33. Plans for collection, laboratory evaluation, and
storage of biological specimens and future use in
ancillary studies
• Protocols should describe details about specimen collection, storage,
and evaluation, including location of repositories
• State whether collected samples and associated participant related data
will be de-identified or coded to protect participant confidentiality

95. Thank You!