[Federal Register: March 13, 2007 (Volume 72, Number 48)]
[Notices]
[Page 11370-11371]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13mr07-65]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0064]
Electronic Case Report Form Submission; Notice of Pilot Project
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Center for Drug Evaluation and Research (CDER) and the
Center for Biologics Evaluation and Research (CBER) in the Food and
Drug Administration (FDA) are seeking sponsors interested in
participating in a pilot project to test the submission of case report
form (CRF) data provided electronically in extensible markup language
(XML) based on the Operational Data Model (ODM) developed by the
Clinical Data Interchange Standards Consortium (CDISC). This pilot will
test the ability of a new data format to support all
[[Page 11371]]
review activity, which our current submission format is incapable of
doing. Data supplied in ODM format by sponsors during the pilot project
will not replace any regulatory requirements for submitting CRFs. We
anticipate that a successful pilot will allow CDER and CBER to
routinely accept CRFs from studies employing electronic data capture
(EDC) in ODM format in marketing applications provided in electronic
format.
DATES: Submit written or electronic requests to participate in the
pilot project by September 10, 2007. General comments on the pilot
project are welcome at any time.
ADDRESSES: Submit written requests to participate and comments
regarding this pilot project to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments
.
FOR FURTHER INFORMATION CONTACT: Armando Oliva, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6310, Silver
Spring, MD 20993-0002, 301-796-0514.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the opportunity to participate in a pilot project
being conducted by CDER and CBER involving the testing of the ODM
standard developed by the CDISC, with the goal of replacing the
existing portable document format (PDF)-based CRFs derived from
clinical trials that use EDC and, therefore, lack paper CRFs. CDISC is
an open, multidisciplinary, nonprofit organization that has established
worldwide industry standards to support the electronic acquisition,
exchange, submission, and archiving of clinical trial data and metadata
for medical and biopharmaceutical product development (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cdisc.org
).
Under existing Federal regulations (21 CFR 314.50), applicants must
provide CRFs with a marketing application. Since November 1997, under
21 CFR part 11, we have accepted CRFs in electronic format instead of
paper. FDA has issued several guidances that provide recommendations
concerning electronic submissions. In the Federal Register of October
19, 2005 (70 FR 60842), FDA announced the availability of a guidance
entitled ``Providing Regulatory Submissions in Electronic Format--Human
Pharmaceutical Product Applications and Related Submissions Using the
eCTD Specifications'' (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/gdlns/esubapp.htm). In section III.E.3. of that
guidance, FDA recommends that applicants submit an individual subject's
complete CRF as a single, PDF file. The guidance recommends that if a
paper CRF was used in the clinical trial, the submitted CRF should be a
scanned image of the paper CRF, including all original entries with
modifications, addenda, corrections, comments, annotations, and any
extemporaneous additions (i.e., audit trail). The guidance further
recommends that if EDC was used in the clinical trial, the applicant
should submit a PDF-generated form or other PDF representation of the
information (e.g., subject profile).
Based on our experience, PDF-based CRFs from clinical trials that
employ EDC are not ideal to support all review activity. Although the
PDF-based CRFs for trials that use EDC can provide a record of the
observations collected during the trial (i.e., the data) and additional
information about what was collected (metadata), they typically do not
provide an audit trail. CDER and CBER are interested in adopting a new,
standard format that can replace the PDF-based CRF and that can
reliably provide all three components of the CRF in an electronic
format: Data, metadata, and audit trail.
The ODM is an XML-based standard that facilitates the electronic
exchange of clinical trial data, metadata, and audit trail. We are
working with CDISC to develop the capabilities within CDER and CBER to
review CRFs using ODM. CDISC employed the current production version
(Version 1.2) of the ODM on the CDISC Web site, and we performed some
initial testing of limited CRF data in ODM. To help in this
development, we are launching this pilot project and seeking sponsors
willing to provide CRFs in ODM format to test our capabilities to
review these files. However, data supplied during the pilot project
will not replace any regulatory requirements for submitting CRFs.
The purpose of this pilot project is to obtain additional
experience with ODM-based CRFs. We anticipate that a successful pilot
will allow CDER and CBER to routinely accept CRFs from studies that
employ EDC in ODM format in marketing applications submitted in
electronic format.
II. Pilot Project Description
This pilot project is part of an effort to improve the quality of
CRFs provided to CDER and CBER in electronic format and to improve the
centers' capability to review these files. Eventually, CDER and CBER
expect to recommend new technical specifications for the submission of
CRFs that are derived from clinical trials that employ EDC and,
therefore, lack paper CRFs.
A. Initial Approach
Because only a limited number of sponsors are needed (i.e.,
approximately five), CDER and CBER will use their discretion in
choosing participants, based on participants' previous experience
submitting CRFs in accordance with existing guidance. Participants
should be willing to provide the same CRFs in two formats: PDF, in
accordance with existing guidance, and ODM. If PDF-based CRFs have
already been submitted as part of an existing new drug application or
biologics license application on file with the agency, then
participants need only provide the ODM-based CRFs with the same
information. Having the same information available in both PDF and ODM
provides the best opportunity to compare the two formats.
B. How to Participate
Written requests to participate in the pilot project should be
submitted to the Division of Dockets Management (see ADDRESSES).
Requests are to be identified with the docket number found in brackets
in the heading of this document.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this pilot
project. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are
to be identified with the docket number found in brackets in the
heading of this document. Received comments may be seen in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: March 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-4451 Filed 3-12-07; 8:45 am]
BILLING CODE 4160-01-S