Free 3625 - Federal

Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research

Form Approved OMB Control Number: 0910-0579 Expiration Date: March 31, 2009 See OMB Statement on Page 3.

DSI COMPLAINT RECORD

· If you wish to report adverse events (adverse effects or adverse reactions) to drugs or report (medical) product problems, contact MEDWatch. · If your complaint is about a research study, please complete this form. · The purpose of this form is for collecting information about the potential scientific or research misconduct, or questionable research practices, involving the use of an FDA regulated drug product. · You must answer the following two questions: (1) Who are you complaining about? and, (2) What is your complaint? If you do not know the answer to any other question in the complaint form, or if you do not wish to provide any additional information, you may leave a blank (unanswered) space following each question.

Who are you complaining about?
Please provide as much information as possible in this section. You must provide the name of a person, company, or organization about whom you are complaining. If you do not know the answer to any other question, or if you do not wish to provide any additional information, you may leave a blank (unanswered) space following each question.
Name of Person, Company, or Organization (Required Information) Address

Email Address (If available)

City

State or Province

ZIP / Postal Code

Telephone No. (If available)

Fax No. (If available)

Country

What type of person or organization are you complaining about?
Bioequivalence Facility Clinical Study Site Institutional Review Board Nonclinical Laboratory Sponsor Clinical Investigator (Study Physician) Contract Research Organization Monitor Study coordinator Other ­ Please specify:

Complaint Information
What is your complaint? (Required Information)

When did the event(s) take place? When did you participate in the study?

FORM FDA 3625 (10/08)

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PSC Graphics (301) 443-1090

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What is/are the name(s) of the study drug(s) or product(s), if known?

What is the type of drug or for what illness is it used? (For example, a drug to treat chest pains, seizures, depression, etc.)

What is/are the study(ies)? Include study title(s) or protocol number(s), if known?

If you know the name(s) of other persons (subjects or staff) who were involved in the study(ies), or anyone else who is willing to voluntarily provide information, please list them and include any available contact information (e.g., telephone number, fax number, email address, mailing address, etc.).

How many subjects were enrolled in the study(ies)?

FORM FDA 3625 (10/08)

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Your Information (optional)
If you do not want FDA to know who you are, do not complete this section. FDA makes a good faith effort to protect the identities of complainants, but no assurance can be given to complainants that their identity will never be disclosed. May the FDA contact you for more information?
Yes No

How may we contact you? If by telephone, please suggest times that are convenient for you?

Please provide your contact information below.
Name Address

Email Address

Telephone No.

Fax No.

City

State

ZIP Code

What is your affiliation with the study?
Study Subject Sponsor Health Professional Ex-Employee FDA Staff University/Institution Staff Clinical Investigator Institutional Review Board Monitor Employee Media Other Government Employee Contract Research Organization Other ­ Please specify:

OMB Statement
Public reporting burden for this collection of information is estimated to average one hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer (HFA-710) 5600 Fishers Lane Rockville, MD 20857 "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number."

FORM FDA 3625 (10/08)

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