Protocol Registration Financial Disclosure Frequently Asked Questions
When does this requirement take effect?
DAIDS requires collection of FD statements effective July 1, 2014. For ongoing studies it is advisable to collect them for all investigators listed on the most current Form FDA 1572.
When must FD forms/Statements be completed?
- At the time a site completes a new or updated Form FDA 1572 where the investigator or sub-investigators change.
- Any time there is a change in an investigator’s financial interest during the course of a clinical trial.
- At a minimum, prior to the initiation of and at the completion of the clinical trial at a site. If the collection of financial disclosure forms/statements is required at additional times (i.e., when a cohort closes, during the course of a trial, etc.), the IND sponsor will inform the study team of this requirement.
Where should completed FD forms/statements be filed?
All original, completed and signed FD forms/statements must be filed and retained in a CRS’s regulatory binder along with the original and/or updated, signed Form FDA 1572 for that study. These forms should not be submitted to DAIDS or the Network Operations Centers unless requested.
Beginning, First Quarter 2015, Monitors will verify during a review of a site's regulatory binder that every investigator listed on all Form FDA 1572s has accurately completed and signed the required FD disclosure form/statement. In the event FD forms/statements are collected, sites will be required to provide the original signed documents and to keep a copy of all forms/statements in the regulatory binders at the site.
Can an electronic signature be used for the disclosure form?
At this time electronic signatures should not be used.
Is the mailing address on the form for the site address or for the investigator completing the form?
The mailing address, email and phone # are for the investigator/sub-investigator completing that form. All FD form are specific for an investigator for a protocol.
Do we need to write the name of the manufacturer of the study drug or the subsidiary or the affiliate in places where there is the XXXX?
Yes, the study drug/pharmaceutical supporter for that specific study should be included in the area with the XXXX.
Are the forms Network Specific?
Yes, each clinical trials network (i.e., ACTG, IMPAACT, HPTN, HVTN, MTN) has developed a generic financial disclosure form/statement for all network studies that are conducted under a DAIDS held-IND. Each network must have their financial disclosure form/statement approved by DAIDS prior to implementation.
For all Non-Network studies that are conducted under a DAIDS held IND, DAIDS has developed a financial disclosure form/statement and this form is available on the Regulatory Support Center (RSC) website.
Does the Investigational Product mean the name of study drug that we use in each protocol?
It’s the Drug/Biologic being investigated in the trial – Not background medications.
For the protocol numbers, should we use one protocol number for one form or we can list every protocol number in one form for each network?
Yes, you have to do a form for each protocol – Just like a Form FDA 1572. We recommend complete ting these forms when filling out your Form FDA 1572 for each study.
What does Participating Pharmaceutical/Biotechnology Company(s) mean?
These are Pharmaceutical collaborators listed in the protocol document.
What is the difference between FD Forms/Statement and Conflict of Interests (COI)?
FD Forms/Statements: US regulation (21 CFR 321.53 and 21 CFR 812.43) requirement outlined for IND sponsors, whereby the IND sponsor will obtain sufficient accurate financial information that will allow an applicant of a marketing application to submit complete and accurate certification of disclosure requirements under 21 CFR 54. As a result, for DAIDS sponsored and/or supported study where DAIDS holds the IND, a process has been developed to ensure that all FD form/statements are completed by all investigators listed on Form FDA 1572.
COI, is U.S. Public Health Service (NIH) policy and the regulation applies to Investigators participating in NIH funded research.