Clinical research data management tasks and definitionsMeredith Nahm, MS,1,2 Constance Johnson, PhD,3 Anita Walden,1,2 Todd Johnson, PhD,2 Jiajie Zhang, PhD2

1Duke Translational Medicine Institute, Durham, NC; 2School of Health Information Sciences, Houston, TX;3Duke University School of Nursing, Durham, NC

Abstract

The tasks associated with clinical research data management have not been systematically identified and defined. We surveyed existing sources to create a draft list and vetted the tasks, their relationships, and their definitions through focus groups, followed by peer debriefing, followed by 2 rounds of broad distribution to the membership of the Society for Clinical Data Management (SCDM). A total of 75 tasks were identified and defined. We present the current version of the tasks.

Introduction

The first formal list of clinical trial data management tasks was published in Data Basics in 1999.1 This task list helped scope the Good Clinical Data Management Practices (GCDMP) document, and provided a foundation for the certification exam. Periodically revisiting foundations like the growing evidence base and the task list is important to our field. We started work in the fall of 2007 to re-survey those tasks associated just with the collection and management of data in clinical research. Limited to the tasks that directly operate on data, this work is considerably narrower than the original task list; for example, project, vendor, and people management tasks are not included. However, this work went a step deeper in searching for authoritative definitions for each task and defining those tasks for which no definition could be found. Additionally, this work went beyond tasks common to industry-sponsored clinical trials to include the broader field of clinical research as defined by the National Institutes of Health. We posit that although we use different methods and different terms to describe them, at some not too abstract level, we all do similar things and can benefit from the richness of each other’s knowledge. Further, data collection and management across the different areas of clinical research share the same literature base. A primary goal of this work is to provide the tasks and definitions to the Medical Subject Headings (MeSH) curation team, to improve the indexing of our literature base and ultimately decrease the fragmentation that exists.

References

1. Bornstein S. Clinical data management task list. Data Basics 1999;5:8-10.

2. Society for Clinical Data Management Certification Handbook. Available at: www.scdm.org. Accessed July 20, 2008.

3. Deitzer JR, Payne PRO, Starren JB. Coverage of clinical trial tasks in existing ontologies. AMIA Proceedings 2006:903.

Funding

The project described was supported by grant number UL1RR024128 to Duke University and grant number UL1RR024148 to University of Texas Health Science Center Houston, from the National Center for Research Resources (NCRR), a compo-nent of the National Institutes of Health (NIH), and its contents are solely the re-sponsibility of the authors and do not necessarily represent the official view of NCRR or NIH.

Background

The initial SCDM task list consisted of 67 tasks grouped into 9 categories but contained no definitions. Later, in 2004, SCDM released their National Certified Clinical Data Man-ager (CCDM) certification exam and associ-ated core competencies. The current core competency set for the exam consists of 112 tasks grouped into 26 categories called core competencies.2

A different approach to identification of clinical research related tasks was taken by Deitzer et al, who abstracted tasks from 20 cancer clinical trial protocols.3 This list, however, is significantly broader than operations performed on clinical trial data.

Methods

Focus groups were held at the 2008 SCDM fall conference and followed by peer de-briefing through the SCDM newsletter. The full task set with definitions was provided to attendees at the 2009 fall conference and later released to the membership. This work was approved by the Duke University insti-tutional review board at the corresponding author’s institution.

Results

A total of 75 tasks were identified. Authori-tative definitions were found for 55 of the tasks. The remainder were defined by the authors.

Conclusion

Task commonalities exist across industry and academically oriented studies. Thus, it is likely that a common vocabulary can be achieved. Maintaining such a task list is important to a discipline because it scopes and defines competencies required for practice in the discipline, and provides a link to the evidence base on which practice recommendations should be made.

Manage Clinical Research Data

Identify data

005

Develop database

244–250

Process data

Design form

representa-tion

012–024

Collect data

Track data

Define data

149, 164, 168–170

Store data, metadata

222–226

Query database

097

Define document

data handling process

029–034, 050–051, 148, 155, 165, 173–177

Support system users

Report status

047–049, 150

Secure data

Measure data

quality

188–208

Source document verify data

Electronic data

acquisition

Transform data

166–167

Data surveillance

Impute data

Integrate data

138–147

Export data

Clean data

Reconcile data

Incremental batch

import

Cumulative batch import

Messaging

Specify measure-

ment method

Annotate form

Specify metadata

Measure/ observe

Abstract data

Record data

Record data

changes

Record provenance

Record state

043–046, 082–091

Comparison Error rate estimation

Choose applicable standards

116, 133

Specify data input structure

Restrict access

Define user roles

Grant access

Revoke access

Key entry

156–163

Interactive voice

response

Optically scan

Import

053–058

Calculate (derive)

data

Code data

110–126, 127–137

Map data

Transpose data

Notify source

072–075

Identify discrepancy

071

Receive resolution

Resolve discrepancy

077–081

Manual review

061–064

Manual Auto Program-matic ID

059, 060, 065, 070, 151, 152, 092–096, 104

Double CumulativeSingle Incremental Add data

Confirm data (as is)

Update data

099–103

Delete data

Manage account

Archive data

Lock database

179–187

Develop load scripts

Develop screens &

tables

036, 037, 039

Program data

validation checks

038, 040

Program reports

041, 042

Validate program-

ming

252–253

Small numbers under activities document mapping to the Society for Clinical Data Management Core Competencies, www.scdm.org

type of

type of type of option

type of part of

part of

part of part ofpart of

part ofpart of

part of

type of

type of

type of

type oftype of

type of

nahm_p_22feb10.indd 1 2/22/10 1:34 PM