Study Data Reviewer’s Guide: CDER Standard Template

Study Data Reviewers Guide Template / March 15
2012
[Type the abstract of the document here. The abstract is typically a short summary of the contents of the document. Type the abstract of the document here. The abstract is typically a short summary of the contents of the document.] / Study data Reviewers Guide

Table of Contents

Study Name and Title

Study Description

Study Design

Protocol specifics

Study Chronology and History

Annotated CRF

External Dictionaries and Code Lists (Look-up lists)

Study Data Tabulations Model – Domains

Overview

Special Purpose Domains

Interventions Domains

Events Domains

Findings Domains

Relationship Domains

Study Data Validation

Acronyms

Regulatory Guidance

Study Data Specifications

Electronic Common Technical Document (eCTD)

Comprehensive Table of Contents Headings and Hierarchy

CDER Common Data Standards Issues Document

Case Report Tabulation Data Definition Specification (CRT-DSS)

Providing Regulatory Submissions in Electronic Format — Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications

Study TaggingFile Specification and Related Files

The eCTD Backbone File Specification for Study Tagging Files

Electronic Regulatory Submissions and Review Helpful Links

Providing Regulatory Submissions in Electronic Format — Standardized Study Data

Study Name and Title

Study Description

Study Design

The Study (trial) design should describe the design methodology and implementation. The CDISC Study Data Tabulations Model (SDTM) includes domains and implementations guidance for specifying the Study Design in a standardized format.

A detailed flowchart depicting the study design is often very helpful to the reader.

Thefollowing depicts the Trial Designmodel of theSDTM IGversion3.1.2.

Domain class TRIAL DESIGN
Name / Description / Structure / Keys
TA / Trial Arms / One record per planned
Element per Arm / STUDYID,ARMCD,TAETORD
TE / Trial Elements / One record per planned
Element / STUDYID,ETCD
TI / Trial Inclusion/Exclusion
Criteria / OnerecordperI/Ecriterion / STUDYID,IETESTCD
TS / Trial Summary / One record per trial summary parametervalue / STUDYID,TSPARMCD, TSGRPID, TSSEQ
TV / Trial Visits / OnerecordperplannedVisit perArm / STUDYID,ARMCD,VISITNUM

TheTrialArms(TA)tabledescribeseachplannedarminthetrial.An armisdescribedasanorderedsequence ofelements,andtheelementmayoccurmorethanonceinagivenarm.ARMCDisthetopicvariable.ETCD, thetopicvariableoftheTEtableisusedintheTAtableasrecordqualifier(i.e.isanadditionalattributeofthe observationrecordasawhole).

TheTrialElements(TE)tabledescribestheelementcode,thedescription,andtherulesforstartingand ending an element. ETCD is the topic variable.

TheTrialInclusion/Exclusioncriteria(TI)tableisnotsubject-oriented.Itcontainsonerecordforeachofthe inclusionandexclusioncriteriaforthetrial,andthusprovidesinformationthatmaynotbepresentinthe subject-level data oninclusionandexclusioncriteria.

TheTrialSummary(TS)tableisnotsubject-oriented.Itisusedtorecordbasicinformationaboutthetrial, suchas trial phase, protocol title and design objectives. TSPARMCD is the topic variable.

TheTrialVisits(TV)tabledescribestheplannedorderandnumberofvisitsinthestudywithineacharm. VISITNUMisthetopicvariable.Thevisitinformationisretrievedfromthevisitschedule.ARMCD,thetopic variable ofthe TA table is usedinthe TV table as record qualifier.

Protocol specifics

Specific protocol details that help reviewers understand the study data. For example, if the protocol included instructions for the investigators to administer concomitant medications if a specific Adverse Event occurred in a treated participant in the study.

Study Chronology and History

The section should include information about the study timeline and other historical facts that may be of interest in the review of the study.

Annotated CRF

Special Considerations and mappings of Case Report Form’s data to domains.

External Dictionaries and Code Lists (Look-up lists)

Study Data Tabulations Model – Domains

Overview

The overview should provide details about the version of the SDTM standard (e.g. 3.1.2) and any additional information regarding the implementation of the standard. This information should include details not provided in the standards’ documentation.

Special Purpose Domains

Comments (CO)

Demographics (DM)

Subject Elements (SE)

Subject Visits (SV)

Interventions Domains

Concomitant Medications (CM)

Exposure (EX)

The Exposures (EX) should include details and explanation concerning the use of the standardized data model. The information may include details and information about Exposures, including tabulation and coding based on the protocol, study processes, and collected data.

Events Domains

Adverse Events (AE)

Disposition (DS)

Protocol Deviations (DV)

The Protocol Deviations (PV) should include details and explanation concerning the use of the standardized data model. The information may include details and information about Protocol Deviations, including tabulation and coding based on the protocol, study processes, and collected data.

Medical History (MH)

Findings Domains

Drug Accountability (DA)

ECG Test Results (EG)

Inclusion/Exclusion Criteria (IE)

Laboratory Test Results (LB)

Physical Examination (PE)

Questionnaires (QS)

Subject Characteristics (SC)

Vital Signs (VS)

Relationship Domains

Supplemental Qualifiers (Suppxx) - Relational Datasets

Related Records (RELREC)

Study Data Validation

SDTM VALIDATION CRITERIA or

ADaM VALIDATION CRITERIA or

SEND VALIDATION CRITERIA or

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Authors: Warfield, D.L. Last printed 5/2/2011 1:34:00 PM

FDA Confidential – INTERNAL USE ONLY