ClinicalTrials.gov Results Reporting from the Ground Up [Presenter Name and contact Info] 1.

ClinicalTrials.gov Results Reporting from the Ground Up

[Presenter Name and contact Info]1

Purpose of Template Presentation

• This presentation was compiled by a team from several CTSA institutions. The presentation can be modified as necessary for your individual institution. You may choose to use the presentation in its entirety or utilize individual sections as needed.

• This presentation addresses Results Reporting. CTSA has compiled other template presentations on Overview of ClinicalTrials.gov and how to input Registration information into the database that you can draw from as well.

• Please note: Results reporting for Terminated Studies is not included in this presentation. For assistance with terminated studies see: http://clinicaltrials.gov/ct2/manage-recs/faq#terminated

2

Outline • Introduction

– Results Reporting Requirement– Preparing for Results Reporting

• The Four Results Modules– Participant Flow– Baseline Characteristics– Outcome Measures– Adverse Events

• ClinicalTrials.gov Review Process• Additional Resources

3

FDAAA Results Requirement RefresherRequired for:

• FDAAA “Applicable Clinical Trials” that• study drugs, biologics, and devices that are approved,

licensed, or cleared by FDA (for any use). When:

• Within 12 months of Primary Completion Date (the final data collection for the primary endpoint)

• If product not approved by Primary Completion Date but is approved later, then results due 30 days after approval

• Delays are possible, primarily for manufacturer or under limited special circumstanceso Pending publication is NOT considered a good cause for

delay

http://clinicaltrials.gov/ct2/manage-recs/fdaaa 4

How are Results Reported?

• Tables are constructed by data providers– “Stand alone” tables - must be meaningful to

people who are not already familiar with the study.

– No narrative conclusions– Columns are study arms– Rows are measures– Type of measure determines specific design of

cells

5

6

Preparing for Results Reporting

• Accurate Registration Entry is Essential for Results Reporting– Be sure your registration is as accurate and

complete before entering results. Registration inaccuracies will be replicated in the results reporting module as some fields auto populate.

7

Preparing for Results Reporting

• TIP: Populating the “Detailed Description” field in your Registration record may assist in the reader’s understanding of the study and will make your Quality Assurance review more effective. Remember, the ultimate goal is clarity for the public.

8

• TIP: If time allows, release your registration one final time to the ClinicalTrials.gov QA review team to ensure you have addressed any errors before inputting results.

Preparing for Results Reporting• Different Modules have Different Structures.• The ClinicalTrials.gov PRS system software is

frequently updated to improve ease of use. Changes in functionality and design of data entry fields are common.

9

See the “What’s New” link on the main menu to

learn about updates to the system

Preparing for Results ReportingIf you are new to Results Reporting, these general resources will

help you prepare:1. How to Submit Your Results homepage

http://clinicaltrials.gov/ct2/manage-recs/how-report

2. Basic Results Data Elements Definitionshttp://prsinfo.clinicaltrials.gov/results_definitions.html

3. PRS User GuideLocated on Main Menu in database

4. 10 minute webinars for each results modulehttp://clinicaltrials.gov/ct2/manage-recs/present

5. Helpful Hints (with common study designs examples) http://prsinfo.clinicaltrials.gov/ResultsExamples.pdf

10

Module 1: Participant Flow

11

FDAAA: Participant Flow Definition

“A table…, including the number of patients who dropped out of the clinical trial and the number of patients excluded from the analysis, if any.”

FDAAA[Sec. 282(j)(3)(c)(i)], http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf#page=82

12

Participant Flow Purpose

• Provide information about the study design by documenting the “flow” of participants through different stages of the study.

• The module should account for all enrolled participants, and make it clear which participants were analyzed.

See ClinicalTrials.gov Participant Flow Module Presentation, Rebecca J. Williams, PharmD, MPH, at http://prsinfo.clinicaltrials.gov/webinars/module5/index .html

13

Participant Flow Data Elements

• Recruitment Details• Pre-assignment Details• Arm/Group*

‐ Title‐ Description

• Period Title(s)*‐ “Overall Study” (default) if

single period

• Milestones‐ Milestone Title‐ STARTED Data*‐ COMPLETED Data*‐ Reason Not Completed

Type (e.g., Death) Data

*Required by ClinicalTrials.govFor definitions of these elements, see the Basic Results Data Elements Definitions: http://prsinfo.clinicaltrials.gov/results_definitions.html

14

Participant Flow

See ClinicalTrials.gov Participant Flow Module Presentation, Rebecca J. Williams, PharmD, MPH, at http://prsinfo.clinicaltrials.gov/webinars/module5/index .html

15

Optional sections but add if it would help public understand the study

better on

Participant Flow Structure• Tabular Format • Arms/Groups – pre-populated from Protocol Section. • Period(s) – Represent different stages of study. • Milestones – Specific events/time points when # of subjects reported.

Must have STARTED and COMPLETED.

16

Example: If your study only has one

period than you would provide the

title of “Overall Study” to the

period and only one Participant

Flow table would be needed for your record.

Participant Flow Structure (Multiple Periods)

17

EXAMPLE: If your study has 3 different periods, you would create 3 tables and provide a descriptive title for each.

STARTED & COMPLETED are required milestones. You can add others milestones to show specific events when the # of participants was reported.

You will track the # of participants that do not complete the period and provide a reason why.

Example adapted from ClinicalTrials.gov‘s Basic Results Helpful Hints, p.13 at http://prsinfo.clinicaltrials.gov/ResultsExamples.pdf

Participant Flow – What is wrong with this?

18

Period: First Intervention Arm A: Drug Bupropion, then placebo

Arm B: Placebo, then Drug Bupropion

STARTED 92 95

COMPLETED 88 95

NOT COMPLETED 4 0

Period: Second Intervention Arm A: Placebo, then Drug Bupropion

Arm B: Drug Bupropion, then placebo

STARTED 88 93

COMPLETED 88 93

NOT COMPLETED 0 0

For the 1st period, there is no explanation of why some subjects did not complete the period.

In the 2nd period, the # of subjects that started does not match the # that finished the 1st period. This may be a data error. Or if there was a washout period between the two periods, you may want to add that as a separate period and explain what happened to the subjects that dropped out.

Get Organized Using the Simple Form

Source: http://prsinfo.clinicaltrials.gov/results_table_layout/ResultSimpleForms.html19

Use one form for each period in your study to gather your data for the Participant Flow module.

Results Overview

20

• This Results Section page is your home base for inputting results. You can access the 4 Results modules from here.

• Click on “edit” next to Participant Flow to edit that module.

21

Participant Flow – Edit Mode

• Within “edit mode”, you can scroll up and down to edit various parts of the Participant Flow. The screen is only partially shown in this snapshot.

Edit Mode – Edit Arm/Group

22

• In edit mode, you can edit the Arm/Group as needed. For example, you can add an arm/group, delete an arm/group or edit the title and description of the arm/group.

Edit Mode – Edit Arm/Group Description

23

• After clicking on the “edit” button to update the arm/group title and description, a text box pops up. Here is a snapshot of Arm A text box. Edit as needed and click on “OK” to save changes.

Edit Mode – Edit the Period

24

Here you can edit information about the Period such as Period Title, # of participants that started and completed the period. You can also note the # that did not complete the period and why.

Edit Mode – Reason Not Completed

25

Within the Period, use the dropdown box when selecting a reason why a subject did not complete a period. There is an “other” option to select if the reason isn’t listed.

Edit Mode – Reason Not Completed

26

If you select “other”, then a blank field appears where you would explain why a subject dropped out.

Edit Mode – Simple but important!

At the bottom of each page in edit mode:

Save: Saves your work and brings you back to the “Results Overview page.”

Cancel: Does not save changes and brings you back to the “Results Overview page.”

27

28

Participant Flow – Quick Tips• Number of participants “started” should match

“Enrollment, Actual” in protocol section– Pre-Assignment Details can be used to explain any

discrepancies in Enrollment, Actual and total number of participants Started.

• Specific Periods to reflect study design and to account for # of participants starting and completing each Period

• Use of Milestones to convey key events– For example, number who received intervention

• Reasons for non-completion

See http://prsinfo.clinicaltrials.gov/ResultsDetailedReviewItems.pdf

Module 2: Baseline Characteristics

Baseline Characteristics

• “A table of demographic and baseline data for the entire trial population and for each arm or comparison group.” Note that only baseline measures for Age and Gender are required; all other baseline measures are optional.

http://prsinfo.clinicaltrials.gov/results_definitions.html explaining FDAAA Sec. 282(j)(3)(c)(i)

Description of Baseline Characteristics Module

• Table of demographic and baseline data for the entire trial population and for each arm or comparison group

• Accommodates different data types:– Continuous: measure of central tendency (e.g.,

mean) and measure of dispersion (e.g., standard deviation)

– Categorical: for each category – (1) a count or (2) measure of central tendency and measure of dispersion

Get organized using the Templates

If it’s in Table 1, it probably belongs in Baseline Characteristics

These will become Default

measures

These will become

User Specified Baseline

Measures

ClinicalTrials.gov Format

“Default” Required Measures

NCT00145249

Default Baseline Characteristics

• Age and Gender are Required Characteristics by default, however, best practice would include other relevant information.

• Choose and display characteristics that are most applicable to your study.

• Region defines “nation”, not states or regions within the U.S.

ClinicalTrials.gov Format

User-Specified Baseline Characteristics

• Do include all meaningful elements that make your study understandable/ useful to others, both demographic and clinical measures, such as baseline values of outcome measures or prior and concurrent treatment characteristics.

• Make sure units and scales are labeled, and understandable – (e.g. what the range of a scale is and what it means. If it’s a well-known scale, within the discipline, refer to it by name and give a citation, if necessary.)

• Use Table 1, if there is a published article or draft.

• If there is no article from which to work, consult with PI.

Post Baseline Characteristics

Baseline Overview

From Baseline Overview you can edit (fill in) or delete default measures, or you can add additional baseline study specific measures.

Edit Baseline Measure

If the measure states what you intended, you can go ahead, and add the data, as here.OR you can Edit the Baseline Measure Description. Make sure you click Save to save your data. Note too, you could Add a Category (which could be a subset, or could be more like a period.)

Baseline doesn’t always mean only at the beginning of the study

More than one period or time point can be considered “baseline” in studies which follow more complicated protocols:•Crossover•Dose escalation•Factorial•Multiple PeriodThat is, not every one of these designs would require posting multiple baselines, but there may be times when the responsible party feels that to have a clear understanding of the findings of the study, it helps to show how baseline characteristics differed between one portion of the study and another.

Description

Sorafenib(Nexavar,BAY43-9006)

Inpatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Each cycle is 28 days. Dose reductions due to toxicities were allowed.

Sorafenib (Nexavar, BAY43-9006)

STARTED 83

COMPLETED 52

Not Completed 31

Reporting Groups

Cycle 1 (28 Days)

Reporting Groups

Description

Sorafenib(Nexavar,BAY43-9006

Inpatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Each cycle is 28 days. Dose reductions due to toxicities were allowed.

Sorafenib (Nexavar, BAY43-9006)

STARTED 52

COMPLETED 44

Not Completed 8

Cycle 2 (28 Days)

Sorafenib (Nexavar, BAY43-9006)

STARTED 44

COMPLETED 33

Not Completed 11

Cycle 3 (28 Days)

Baseline Measures

Sorafenib (Nexavar, BAY43-9006

Number of Participants 83

Age Continuous[units: years]Median (Full Range)

Cycle 1 (n=83) 61 (33 to 80)

Cycle 2 (n=52) 63 (33 to 72)

Cycle 3 (n=44) 55 (33 to 72)

Example of Multiple Baselines shown

From supplemental slide provided at Train-the-Trainer workshops; courtesy of ClinicalTrials.gov.

Using Categories for Multiple Periods/ Multiple Baselines

Note how when another Category is added, it needs a title as well as data. Remember to save!

Important Quality Checks

Review record to ensure: • Categories do not overlap and all categories are

presented• Range and direction of scores in baseline

characteristics description are explained• Terms are understandable to the general public. Use

footnotes if necessary to describe a score.

MODULE 3:OUTCOME MEASURES & STATISTICAL ANALYSES

45

FDAAA*: Outcome Measures

“…a table of values for each of the primary and secondary outcome measures for each arm of the clinical trial…including the results of scientifically appropriate tests of the statistical significance of such outcome measures.”[Sec. 282(j)(3)(C)(ii)]

*Food and Drug Administration Amendments Act of 2007

46

Outcome Measures Purpose

The Outcome Measures module displays the results and associated statistical analyses for each prespecified primary and secondary outcome measure. Other outcome measures may also be included.

See ClinicalTrials.gov Outcome Measures and Statistical Analyses Module Presentation, Deborah A. Zarin, M.D. at http://prsinfo.clinicaltrials.gov/webinars/module7/index.html

Outcome Measures – Data Elements• To set up table

– Arm/Group title* and Description– Number of Participants Analyzed*

• To Describe specific Outcome Measures– Outcome Measure Title*– Outcome Measure Description– Unit of Measure*– Outcome Measure Time Frame*– Measure Type (e.g., mean, median)*– Measure of Dispersion/Precision (e.g., Standard

Deviation)*• Data**Required by ClinicalTrials.govhttp://prsinfo.clinicaltrails.gov/results_definitions.html 48

Outcome Measures Data Elements

• Outcome Measure Type*– Options

Primary Secondary Other Pre-specified Post-hoc

• Outcome Measure Reporting Status*• Outcome Measure Safety Issue? (Y/N)

*Required by ClinicalTrials.govhttp://prsinfo.clinicaltrails.gov/results_definitions.html

49

50

Field = Timeframe

Field = Part of Outcome Measure Title

Field = Part of Outcome Measure Title

Draft Outcome Measure Title: Proportion of Participants with Decrease in Anxiety ≥ 50% on the Hamilton Anxiety Rating Scale

Outcome measure information: Please be specific as possible.

• Title: include the name of the specific measure. Avoid using verbs, that is, do not put “To determine…”

• Time Frame: must have a time point at which the outcome is assessed for the specific metric used (hours, days, weeks, years) Hint: specify which study day it is measured - do not use “until the end of study or death”.

• Description: describes what will be measured, not why it is measured. If the outcome measure is a questionnaire or scale, provide the range and what low or high scores mean.

• Safety Issue: Is this outcome measure assessing a safety issue?

Outcome Measure

51

Example of an Outcome Measure What is wrong with this?

52

Example of an Outcome Measure What is wrong with this?

53

Get Organized Using the Simple Form

54Use one simple form for each Outcome Measure you are entering into the database.

© 2009 Infectious DiseasesSociety of America

Pappas PG, Chetchotisakd P, Larsen RA et al. Clin Infect Dis. 2009

Outcome Measures – Journal Article Format

55

Journal articles have similar information to ClinicalTrials.gov, just presented in a different format!

Outcome Measures – ClinicalTrials.gov Format, Public View

NCT00145249 56

ClinicalTrials.gov Format (cont.), Public View

NCT00145249

57

Data Elements – Statistical Analyses*

58

Basic Results Data Elements Definitions: http://prsinfo.clinicaltrials.gov/results_definitions.html

*The law requires scientifically appropriate tests of statistical significance.

Go to Outcome Overview to Add Statistical Analysis

59

Add Outcome Statistical Analysis

60

Add Outcome Statistical Analysis

61

Choose the statistical test from the drop-down box.

Completed Outcome Measure and Statistical Analysis

62

Outcome Measures and Statistical Analyses – Quick Tips

• Results, including study or outcome conclusions, are not provided in narrative form.

• The Title and Description are comprehensible and descriptive (e.g., Arm A, B, C is not informative).

• For measures obtained using a scale:– Name of scale is provided in “Measure Title.”– Range and direction of scores (0 = worst; 10 = best) are indicated in

“Measure Description.”– “Unit of Measure” is “units on a scale” if no other unit.

See http://prsinfo.clinicaltrials.gov/ResultsDetailedReviewItems.pdf

63

Module 4: Adverse Events

64

Description of the Adverse Events Reporting Module

The Adverse Events Module is a summary of results for SAEs and AEs that are collected during the study

• Data should be tracked and reported in accordance with the procedures for data collection as defined in the protocol

• Adverse Events are reported as summary data at the end of the study

• SAEs and AEs are presented in separate tabular format

• Not “real time” adverse event reporting while the study is ongoing

• Use the Adverse Events Reporting Additional Description to provide information on analysis population, methods of event data collection and other details

http://prsinfo.clinicaltrials.gov/results_definitions.html65

Adverse Events Reporting

Adverse Event (AE) “Unfavorable changes in health, including abnormal laboratory findings, that occur in trial participants during the clinical trial or within a specified period following the trial. Two types of adverse event data are to be reported: "Serious" and "Other (Not Including Serious)" adverse events.”

http://prsinfo.clinicaltrials.gov/results_definitions.html#AdverseEventsDefinition

66

Adverse Events Reporting

• Serious Adverse Events (SAEs)• A table of all anticipated and unanticipated

serious adverse events grouped by organ system, with number and frequency of such events in each arm of the trial

• Other Adverse Events (AEs)• A table of anticipated and unanticipated

adverse events that exceed 5% within any arm of the trial, grouped by organ system, with number and frequency of such events in each arm of the trial.

67

Adverse Event Reporting• Adverse Events are entered by 2 modes

– Manual entry directly into the PRS browser based interface – Download and Upload link

• Use the predefined Adverse Events Simple form for preparation – Simple form (template) is helpful in organizing results entry– Data is segmented and compiled by

• Frequency of Event• Total Number of events• Number of events (deaths, myocardial infarction, fever, etc.)• Number events per participant

68

Getting Organized Using the Serious Adverse Events Template

69http://prsinfo.clinicaltrials.gov/results_table_layout/ResultSimpleForms.html

Getting Organized Using the Other Adverse Events Template

70http://prsinfo.clinicaltrials.gov/results_table_layout/ResultSimpleForms.html

Adverse Events• Frequency Threshold for Reporting Other (Not Including Serious) Adverse

Event

– The frequency of Other (Not Including Serious) Adverse Events that, when exceeded within any arm or comparison group, are reported in the results database for all arms or comparison groups. The number must be less than or equal to the allowed maximum (5%), and must not include any symbols (e.g., >= , %). Expressed as a percentage.

For example, a threshold of 5 percent indicates that all Other (Not Including Serious) Adverse Events with a frequency greater than 5 percent within at least one arm or comparison group are reported.

• Total Number Affected by any Other (Not Including Serious) Adverse Event above the Frequency Threshold

– Overall number of participants affected by one or more Other (Not Including Serious) Adverse Events above the specified Frequency Threshold (e.g., 5%).

71

Click Edit Results to access Adverse Events Module

Manual Entry of Adverse Events

72

Manual Entry of Adverse Events

73

Within Edit Results, Click Edit to access Adverse Events Module

74

Click Add here to build the Serious Event List

Click Edit here to enter SAE Totals

Click Edit to enter Time Frame, Source and Assessment Type Information

Manual Entry of Adverse Events

Manual Entry of Adverse Events

75

Enter Adverse Event Terms etc. * denotes required fields

76

Manual Entry of Adverse Events

Click Edit to enter results for each event

Entering Events is not required

A Note will appear when Events is left blank.

When results are availble, please enter Events

Downloading/Uploading Adverse Events

• Click “Download or Upload Adverse Events” Link

77

Download Adverse Events Template

78

Sample AE Template Download

79

Upload Adverse Events

80

Upload the fileSelect your completed Spreadsheet using Browse and select OpenSelect Adverse Event Type (Serious or Other)Select the file format (Excel Workbook or Excel 97-2003)Select the green Upload button

Serious Adverse Events (Public site view)

81

Other Adverse Events (Public site view)

82

Important Quality Checks• The Total Number of Participants at Risk should be equal to the Total Number of

participants Started. (Refer to the Participant Flow)– Adverse Events Reporting Additional Description can be used to explain the Analysis Population

(any discrepancies in total number of participants Started Participant Flow).

• The number of Events is not required when entering Adverse Events, however a Note will occur for each results entry field that is left blank. You are not required to address Notes in order to submit your record to ClinicalTrials.gov.

• Adverse Events results are reported as a summary at the end of the study , not real-time while the study is ongoing.

• Be consistent when entering event names for AEs (for example Anemia, angina) Enter either all lower case or upper case letters. Adverse event names will appear in the case as they are entered.

• Corrections for text fields in the AE module must be corrected using Modify under event.

• When using the Download or Upload Adverse Events link, the upload will be rejected if the columns in your file do not match the order and content in the PRS. 83

ADDRESSING QA COMMENTS

84

ClinicalTrials.gov PRS QA Process

• When data entry is complete, the Responsible Party approves and releases the registration record.

• After the registration record is released, the ClinicalTrials.gov QA staff performs a manual review of the record for consistency and quality. (See Protocol/Results Review criteria).

• The Quality Review focuses on logic, internal consistency, apparent validity, meaningful entries, and formatting.

85

ClinicalTrials.gov PRS QA Process

• If QA identifies issues requiring attention, comments are noted and the study record is reset to “In Progress” by ClinicalTrials.gov.

• The record owner and RP will receive notifications from ClinicalTrials.gov regarding review comments and current record status.

• Identified issues must be addressed, and the Responsible Party must approve, and re-release the record.

• If the record passes ClinicalTrials.gov QA, it is Released for publishing on the ClincalTrials.gov website.

86

ClinicalTrials.gov PRS Results Data Flow

Data Provider Inputs Results Data. RP “approves” & “releases” data to ClinicalTrials.gov.

ClinicalTrials.gov conducts QA review of data within 30 days.

APPROVES: ClinicalTrials.gov

posts data on public website.

RESETS to “in-progress”:

ClinicalTrials.gov provides PRS

comments to Data Provider.

87

Accessing PRS Review Comments

88

Records with PRS Comments may be accessed using the “PRS Review Comments” link from the Records drop down box.

Accessing PRS Review Comments

89

http://www.clinicaltrials.gov

Accessing PRS Review Comments

90

Click the Edit Link

Each comment is logged under related module

Comments are highlighted in Pink

ClinicalTrials.gov PRS Review Comments

91

ClinicalTrials.gov PRS QA Comments

• Common Areas for QA Comments: • General

Expand acronyms and abbreviations Review for spelling errors Proper formatting

• Content Brief title is in lay language and includes condition and interventions

evaluated in this study Review for internal consistency Check overall recruiting status and compare it to the study start date, the

primary completion date, and the study completion date listed

92

ClinicalTrials.gov PRS QA Comments

Outcome Measures• Enter what is being measured, not why it is being measured

‐ General terms as “safety,” “tolerability,” or “feasibility” are not sufficient • Time frame, must be specific

‐ “At Follow up” or “end of study” is not specific ‐ Most outcome measures have one time point‐ Each unique combination outcome measure and time frame should be entered

separately • Time frame for change of outcome measure

‐ Time frames indicate time period over which change occurred– generally two points should be entered

‐ Time-to-event should include a time over which the event will be assessed• When entering data into ClinicalTrials.gov

‐ Enter arms and interventions Specify each study arm first Specify each intervention Assign each intervention to one or more study arms

93

Sample QA Comment Examples

• QA Comment:– Please note that the Primary Outcome Measure is vague. The following is a

definition for Primary Outcome Measure: "Specific key measurement(s) or observation(s) used to measure the effect of experimental variables in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment." Please modify the Primary Outcome Measure, as appropriate, and re-release the record

• QA Comment:– The Outcome Measure is reporting a change. Please provide complete information:

• Specify relevant time points (e.g., baseline and 48 weeks) in the Time Frame.• Specify change calculation details in Outcome Measure Description if more than two

time points.

94

• QA Comment– The Time Frame provided is not specific. The Time Frame should specify the

specific time point(s) at which the outcome measure was assessed and for which data are presented. (e.g.,"up to 2 weeks"). An average time period may also be acceptable.

• QA Comment– The Measure includes a scale. Please complete the scale information:

• Specify Full Scale Name and Construct (i.e., indicate what the scale measures if not clear from name).

• Include all scale ranges (i.e., minimum and maximum scores) required to interpret any values in the data table. For example, if the *total* score is reported, the *total* range should be provided. If subscale scores are reported, the range for each subscale should be provided.

• For each scale range provided, specify which values are considered to be a better or worse outcome (i.e., For the minimum and maximum values in the range, do higher values represent a better or worse outcome?)

• Use "Units on a scale”

Sample QA Comment Examples continued

95

QA Comment:Please review entire record and expand all acronyms and abbreviations (and include acronym in parentheses) at least the first time used in *both* the Protocol and Results section. The Spelling link at the top of the "Edit Protocol Record" page can be used to help locate and spell out unexpanded acronyms. (e.g., "INR")

QA Comment:The Enrollment number in the protocol section conflicts with the number of participants Started in the Participant Flow module. Please verify and correct either or both of these data elements, or otherwise explain the apparent discrepancy in Pre-Assignment Details, as appropriate (e.g., if 12 participants were excluded for the given criteria, please make this explicit).

QA Comment:Number of Participants Analyzed is not consistent with numbers provided in any of the rows in the Participant Flow Module. Please verify numbers and/or explain the discrepancy in Analysis Population Description, as appropriate.

Sample QA Comment Examples continued

96

QA Comment- Quick Tips• QA Comments can be accessed from the Main Menu “QA Review Comments” link or within the record by clicking

• To locate the specific issues noted in the PRS Review Comments, use the Expand Selection link

• When addressing QA Comments regarding the number of participants in any section, start with the Participant Flow and take a systematic approach through the modules to make certain all participants are accounted for including the Enrollment Number from the Protocol Section.

• If you ever have questions on QA comments, you may contact your institutional contact and/or [email protected] for assistance.

97

This slide set was made possible by a collaboration of CTSA organizations (Mayo Clinic, Partners, University of Michigan Medical School, Duke University) and the National Library of Medicine.   

The Clinical and Translational Science Awards Program (CTSA) is part of the Roadmap Initiative, Re-Engineering the Clinical Research Enterprise and is funded by the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH).

98