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Use of Electronic Health Record Data in Clinical Investigations - PharmaFacts
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Use of Electronic Health Record Data in Clinical Investigations

Use of Electronic Health Record Data in Clinical Investigations

Guidance for Industry

DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.

Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document, contact (CDER) Cheryl Grandinetti at 301-796- 2500, (CBER) Office of Communication, Outreach and Development, 800-835-4709 or 240- 402-8010, or CDRH Program Operations Staff at 301-796-5640.

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U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH)

May 2016 Procedural

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I:/42261.dft 05/12/16

Use of Electronic Health Record Data in Clinical Investigations

Guidance for Industry

Additional copies are available from:
Office of Communications, Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
10001 New Hampshire Ave., Hillandale Bldg., 4
th Floor
Silver Spring, MD 20993-0002
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353
Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm and/or
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research

Food and Drug Administration
10903 New Hampshire Ave., Bldg. 71, Room 3128
Silver Spring, MD 20993-0002
Phone: 800-835- 4709 or 240-402-8010
Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm and/or
Office of Communication and Education
CDRH-Division of Industry and Consumer Education
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 66, Room 4621
Silver Spring, MD 20993-0002
Phone: 800-638-2041 or 301-796-7100; Fax: 301-847-8149
Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm

U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH)

May 2016 Procedural

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I. II. III. IV. V.

A.

B. VI.

A. B. C. D. E.

VII.

Contains Nonbinding Recommendations

Draft — Not for Implementation

TABLE OF CONTENTS

INTRODUCTION............................................................................................................. 1

SCOPE ............................................................................................................................... 2

BACKGROUND ............................................................................................................... 3

INTEROPERABILITY .................................................................................................... 4

BEST PRACTICES FOR THE USE OF EHR DATA IN CLINICAL INVESTIGATIONS.......................................................................................................... 5

Use of ONC-Certified Health Information Technology .............................................................6 Use of EHRs Not Certified by ONC ............................................................................................. 6 OTHER GENERAL CONSIDERATIONS FOR BEST PRACTICES ....................... 7 Use of EHRs in Clinical Investigations ........................................................................................ 7 Data Modifications......................................................................................................................... 7 Audit Trails .................................................................................................................................... 8 Informed Consent .......................................................................................................................... 8 Privacy and Security of Data ........................................................................................................ 8

INSPECTION, RECORDKEEPING, AND RECORD RETENTION REQUIREMENTS............................................................................................................ 9


CLICK HERE FOR FULL GUIDANCE