IMPAACT Clinical Investigators
Disclosure of Financial Interests and Arrangements for US FDA
From:
Sent:
To:
Cc:
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Attachments:
Megan Valentine (mvalentine@fhi360.org)
Wednesday, September 17, 2014 11:19 AM
IMPAACT.PROTP1114@fstrf.org
Jennifer Bryant
IMPAACT P1114/CIR285: DAIDS Guidance on FDA Financial Disclosure
IMPAACT P1114 Financial Disclosure August 2014.docx
Dear All –
This message is to provide an update on current DAIDS guidance for collection of financial disclosure information in
compliance with US Food and Drug Administration (FDA) regulations applicable to studies conducted under an
Investigational New Drug (IND) application (21 CFR 54.4).
The requirement to collect financial disclosure information for studies conducted under an IND is not new; however, DAIDS
has issued new guidance on collection of this information (effective 1 July 2014) and study monitors will begin to assess
compliance with this guidance beginning in the first quarter of 2015. For reference, the guidance can be accessed at the
following website:
http://rsc.tech-res.com/protocolregistration/
Please note that the requirement to collect financial disclosure information for IND studies is distinct from NIH requirements
to identify conflicts of interest, which is done periodically through the Office of HIV/AIDS Network Coordination (HANC).
While there may be some overlap in the information collected through these two mechanisms, as described below in more
detail, documentation of financial disclosure information must be compiled and maintained on-site for each IND study
conducted at each site. As a further clarification, if your site is conducting more than one IND study, financial disclosure
documentation must be maintained separately for each study.
The attached form is provided to assist with collection of financial disclosure information for P1114/CIR285. A copy of
this form must be completed by the 1077BF Investigator of Record at each site as well as by
each person listed on the FDA Form 1572 for this study. When completing the form, each person must
disclose their own financial interests as well as those of their spouses and dependent children. The forms should be
completed as soon as possible by all study staff currently listed on the FDA Form 1572. Going forward, if any new staff are
added to the FDA Form 1572, these persons must also complete a financial disclosure form. Upon completion of the study,
as part of study close-out procedures, all forms will be reviewed and updated as needed to add any new financial interests
that may have occurred since initial completion of the forms.
All forms must be available for review by site monitors and other sponsor and IMPAACT representatives, as well as FDA
representatives; as mentioned above, study monitors will begin to review these forms in the first quarter of 2015. However,
the forms need not be submitted to DAIDS or the IMPAACT Operations Center unless requested.
Please let me know if you have any questions about this message or the attached form.
Thank you,
Megan
IMPAACT Clinical Investigators
Disclosure of Financial Interests and Arrangements for US FDA
Please complete all of the information below, including providing your signature where indicated.
1. Protocol Number: IMPAACT P1114/CIR 285
2. Protocol Title: A Phase I Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory
Syncytial Virus Vaccine RSV cps2, Lot RSV#005A, Delivered as Nose Drops to RSV-Seronegative
Infants and Children 6 to 24 Months of Age
3. Site Name/Number: <INSERT SITE NAME/NUMBER>
4. Participating Pharmaceutical/Biotechnology Company(s): National Institutes of Health (Laboratory of Infectious Diseases)
5. Principal Investigator/Subinvestigator name as listed on 1572 : <INSERT INVESTIGATOR NAME>
Principal Investigator
Subinvestigator
6. Investigator Contact Information:
<INSERT INSTITUTION NAME, TELEPHONE NUMBER, FAX NUMBER, E-MAIL ADDRESS>
7. Indicate by marking YES or NO if any of the financial interests or arrangements of concern to FDA (as described below)
apply to you, your spouse, or dependent children.
Any financial arrangement entered into between you and any participating pharmaceutical/ biotechnology
company whereby the value of the compensation to you for conducting the study could be influenced by the
outcome of the study? This includes compensation that could be greater for a favorable clinical result,
compensation in the form of an equity interest in any participating pharmaceutical/biotechnology company or
compensation tied to sales of the product tested in the above study such as a royalty interest.
YES
NO
If yes, please describe:
Any significant payments of other sorts from any participating pharmaceutical/biotechnology company? This
could include, for example, payments made to the investigator or the institution to support activities that have a
monetary value greater than $25,000 (i.e. a grant to fund ongoing research compensation in the form of
equipment, or retainers for ongoing consultation of honoraria).
YES NO
If yes, please describe:
Any proprietary interest in the product tested in the study such as a patent, trademark, copyright, or licensing
agreement. ?
YES NO
If yes, please describe:
Any significant equity interest in any participating pharmaceutical/biotechnology company? This would include,
for example, any ownership interest, stock options, or other financial interest whose value cannot be easily
determined through reference to public prices, or an equity interest in a publicly traded company exceeding
$50,000.
YES NO
If yes, please describe:
In accordance with 21 CFR § 54.1 to 54.6, I declare that the information provided on this form is, to the best of my
knowledge and belief, true, correct, and complete. Furthermore, if my financial interests and arrangements, or those of my
spouse and dependent children, change from the information provided above during the course of the study or within one
year after the last patient has completed the study as specified in the protocol, I will notify DAIDS promptly.
8. Signature
IMPAACT Disclosure of Financial Interests and Arrangements
FINAL: 30 July 2014
9. Date:
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