An In-Depth Guide to Form FDA 1572
What is the Form FDA 1572?
The Form FDA 1572 is a form issued by the United States Food and Drug Administration (FDA). It is a document that must be completed and submitted by sponsors and investigators conducting clinical trials in the United States. This form provides the FDA with important information about the clinical trial, such as the protocol, investigator qualifications, and other important information.
CCRPs provides principal investigator certification to ensure accuracy and efficiency for form completion and compliance.
Who is Required to Complete the Form FDA 1572?
The Form FDA 1572 must be completed and submitted by sponsors and investigators involved in clinical trials conducted in the United States. The sponsor is the organization that is responsible for the conduct of the clinical trial, and the investigator is the individual responsible for the conduct of the trial at a specific site.
How to Complete the Form FDA 1572?
Completing the Form FDA 1572 can be a daunting task for investigators and sponsors. However, it is important to understand the information requested on the form, as well as how to accurately and completely fill out the form. A few tips for completing the form include: thoroughly reviewing the instructions before filling out the form, carefully reading each item on the form and providing complete and accurate information, and providing all required information, such as signatures and dates.
Steps to Filling out FDA 1572 Form:
Write the name of the investigator at the top of the form. For example, enter “John Smith” as the Investigator Name.
Enter the address of the investigator in the next line. For example, enter “123 Main Street, Anytown, USA 12345” as the Investigator Address.
Enter a phone number for contact purposes in either a local or international format (e.g., “1-800-555-1234” or “+1 123 456 7890”).
Enter a valid email address associated with the investigator in the provided field (e.g., [email protected]).
List any previous investigational drug and device studies that have been performed by this investigator under FDA oversight (if applicable). For example, enter “CT-001, DB-002” as Previous Investigational Studies Conducted Under FDA Oversight.
Indicate whether you are requesting approval to conduct clinical trials with drugs or devices by checking one of two boxes: Drugs or Devices/Biologics/Medical Devices/Other Products Regulated by FDA (e.g., select “Drugs” if you are requesting approval for clinical trials with drugs).
Follow up with information about which specific drugs or devices will be used in your studies (e.g., enter “Lipitor, Celebrex” for drugs and/or “Defibrillator XF7500, Pacemaker YZ2300” for medical devices).
Specify how many new indications or dose regimens you will be studying with each drug or device (e.g., enter 2 for Lipitor and 1 for Celebrex).
Provide details about any preclinical studies conducted to evaluate safety and efficacy data related to your proposed clinical trial (if applicable; e.g., provide details about animal models used and results obtained from these tests)
Describe any other research activities related to FDA product regulation that have been conducted by yourself or associates at your organization (if applicable; e.g., enter “Phase II safety study on Lipitor conducted in 2018”)
Sign and date the form after carefully reviewing all information entered into it
FAQs for Form FDA 1572
What is the Statement of Investigator, Form FDA 1572?
The Statement of Investigator, Form FDA 1572, is a document that must be completed and signed by the lead investigator for each clinical investigation conducted under an Investigational New Drug Application (IND). It is used to provide information about the qualifications of investigators conducting studies with investigational drugs.
Why does this form need to be completed by an investigator?
This form needs to be completed by an investigator to ensure that they are qualified and have the necessary experience and expertise to conduct a safe and ethical clinical trial. This form also serves as affirmation from the investigator that he or she has read and understood the protocol of the clinical investigation in question, as well as any other information pertinent to the study provided by the sponsor or sponsor-investigator.
When must this form be completed and signed by an investigator?
The form must be completed and signed by an investigator at or before initiation of a clinical investigation which involves use of an investigational drug. The form must also be updated or a new 1572 must be completed and signed by an investigator if there is new or changed information relevant to the study.
Must the investigator be a physician? What are the minimum qualifications of an investigator?
An investigator does not need to be a physician, but should meet certain criteria set forth by FDA such as having sufficient training, knowledge, and experience pertinent to the type of research being conducted; having access to medical records relevant to studies being conducted; understanding good clinical practice requirements; following protocols; and obtaining informed consent from research participants.
Does the 1572 need to be submitted to FDA?
Yes, this form needs to be submitted to FDA along with supporting documents prior to initiation of a clinical trial involving use of an investigational drug. Even if a foreign clinical study is not conducted under an IND, investigators who conduct such studies still may need to sign a 1572 in certain circumstances.
If a clinical investigation is not conducted under an IND or is for a medical device, must investigators sign a 1572?
A sponsor may conduct a foreign clinical study under an IND only in situations where it does not qualify for exemption from IND regulations due to lack of assurance that subject protection will be maintained without oversight from FDA. If such conditions are met then sponsors must submit an IND application prior initiating the foreign study in order for it to comply with applicable regulations.
Must investigators who conduct studies outside of the United States sign a 1572?
Yes, according to the Food and Drug Administration (FDA), all clinical investigators conducting studies on FDA-regulated products that require an Investigational New Drug (IND) application must sign a Form FDA 1572. This form is used to confirm that the investigator understands their obligations and responsibilities related to conducting IND-related studies.
If a foreign clinical study is being conducted under an IND, what are the investigator's responsibilities with respect to local laws and regulations?
When conducting foreign clinical trials under an IND, investigators must comply with both local laws/regulations as well as those set forth by the FDA in 21 CFR Part 312. This includes ensuring that good clinical practice standards are followed and that any applicable ethical considerations are taken into account when designing and implementing the study protocol. In order to ensure compliance with local laws, investigators may need to obtain permission from national or regional regulatory authorities before beginning the trial. Additionally, depending on the country in which a foreign clinical trial is conducted, additional requirements such as language translations of informed consent forms may be necessary.
For foreign clinical studies conducted under an IND, how can an investigator sign the 1572 when he/she knows he/she cannot commit to all of the requirements on the form, specifically IRB membership (21 CFR 56.107)?
In order for an investigator to sign a Form FDA 1572 for a foreign clinical study under an IND even if they know they cannot commit to all of its requirements (specifically IRB membership), they should discuss this issue with their sponsor prior to signing it in order to find out what alternative arrangements can be made. Furthermore, sponsors should consider both local laws/regulations as well as ICH standards when making these arrangements so that appropriate safety measures can be taken. For instance, sponsors may choose to contract independent consultants or external experts who are familiar with good clinical practice standards in order to review data gathered during trial activities at sites located outside of United States jurisdiction.
If a sponsor chooses to conduct a foreign clinical study (or operate non-US sites in a multinational study) under an IND and the investigators at these non-US sites comply with ICH E6 Good Clinical Practice Consolidated Guidance, would the non-US investigators also be in compliance with FDA's IND requirements under 21 CFR Part 312?
When conducting foreign clinical trials under an IND, compliance with ICH E6 Good Clinical Practice Consolidated Guidance alone may not guarantee full compliance with 21 CFR Part 312 requirements set by the FDA. Although ICH standards provide general guidance on how research should be conducted ethically and safely within different jurisdictions around world, some countries have rules or regulations in place which differs from those established by ICH E6 Good Clinical Practice Consolidated Guidance or which might amend them slightly; therefore potential discrepancies between these two sets of regulations need to be taken into consideration when designing trial protocols for international trials subject to FDA jurisdiction. Furthermore, sponsors should ensure that all parties involved in such trials understand their individual responsibilities related executing Research Ethics Committee approval processes required for each country included in study protocol design prior commencing trial activities at each site outside US jurisdiction
Must foreign clinical study sites in a multinational study that includes domestic sites be conducted under an IND?
Yes, all foreign clinical study sites that are part of a multinational study must be conducted under an IND. The sponsor must submit an application to the FDA for approval to conduct the study and provide detailed information about the site, such as personnel qualifications, resources and facilities available at the site, and protocol for conducting the research. The IND application includes protocols and other information describing how a proposed clinical investigation will be conducted.
How does a sponsor submit information to FDA about a foreign clinical study that was not conducted under an IND?
The sponsor must submit an Investigational New Drug (IND) Application to the FDA if they wish to conduct a foreign clinical study which has not been previously approved by the FDA. The sponsor should include detailed information regarding the proposed clinical trial, including the proposed protocol, safety measures put in place to protect subjects participating in the trial, qualifications of personnel involved in conducting or supervising the trial, and any other information which will help demonstrate compliance with applicable regulations.
Should a new form be prepared and signed when the OMB expiration date is reached?
No, there is no need for sponsors to prepare or sign any new forms when submitting an Investigational New Drug (IND) Application or when seeking approval from FDA for any particular clinical trial. However, sponsors must follow all applicable laws and regulations related to their research activities and comply with requirements set forth in relevant documents such as Form 1572 (Declaration for Clinical Investigations Involving Human Subjects), Form 3454 (Statement of Investigator), and Form 3753A (Clinical Investigator's Brochure).
Does FDA expect a double-sided 1572, or is a two-page document printed from the FDA website acceptable?
The FDA requires sponsors to submit Form 1572 as part of their IND application as both single-sided copies and double-sided copies. The form should be completed according to applicable regulations outlined by 21 CFR 312.23(a)(7). Sponsors may not use double-sided copies of documents obtained from websites hosted by other organizations, including those belonging to different government agencies or non-profit institutions..
How should the 1572 be completed?
Form 1572 should be filled out completely by each investigator listed on it who is responsible for conducting or supervising certain aspects of research activities at any given site. This includes providing all necessary details such as person’s name, address/location(s), contact information (e-mail address/phone number/fax number etc.), signature(s) etc., along with listing any degrees/licenses held by him/her that show he/she is qualified to conduct/oversee said research activities being funded through this particular project. Furthermore important section detailing ‘Financial Disclosure’ needs special attention especially since this form also serves purpose of informing potential participants about potential conflicts of interest pertaining to investigator’s involvement in these studies alongside his/her salary details etc. So it is crucial that this section is filled out completely without leaving out any significant details so that true picture can be presented in front of future volunteers who might decide whether they want participate in said studies or not based on aforementioned disclosure
Review Questions for FDA Form 1572
What is FDA Form 1572?
A) A form that must be completed and signed by the clinical investigator when a study is initiated, revised, or discontinued
B) A form that must be completed by all patients participating in a study
C) A document used to report adverse drug events to the FDA
D) A document used to collect information about the safety and effectiveness of drugs
Answer: A) A form that must be completed and signed by the clinical investigator when a study is initiated, revised, or discontinued. Explanation: The FDA Form 1572 is an agreement between investigational sites and the FDA. It outlines key elements of studies conducted at those sites such as background qualifications of investigators and staff, source documents, records maintenance, reporting requirements and procedures for handling drugs used in clinical trials.
What type of information must be provided when completing FDA Form 1572?
A) Personal information about each individual participant in a trial
B) Information about drugs being tested in a trial
C) Financial information from sponsors involved in the trial
D) Information about laboratory tests performed during the trial
Answer: B) Information about drugs being tested in a trial. Explanation: The FDA Form 1572 requires that the investigator identify all drugs to be administered during the investigation (e.g., active ingredient names and doses), along with any other products that may affect laboratory results such as vitamins or minerals. This will help ensure accurate record keeping throughout the trial.
Who is responsible for ensuring accuracy on FDA Form 1572?
A) The clinical investigator conducting the study
B) The sponsor of the study/trial
C) The patient participating in the study/trial
D) All of the above
Answer: D). All of the Above. Explanation: Accuracy on FDA Form 1572 is essential since it serves as an agreement between investigational sites and the Food & Drug Administration (FDA). Thus, both sponsors and clinical investigators are responsible for ensuring accuracy on this form, as well as patients who participate in studies/trials should they provide any data or information required by this form.
When does an individual need to submit an updated version of FDA Form 1572?
A) When enrolling new patients into a clinical trial
B) When changes are made to protocols related to a given clinical trial
C ) When making changes to personnel associated with a given clinical trial
D ) All of the above
Answer: D). All of the Above Explanation: An updated version of FDA Form 1572 needs to be submitted when enrolling new patients into a given trial; when changes are made to protocols related; or when personnel associated with a given clinical trail have changed since its initiation or last update. This helps ensure accuracy so that all parties involved have access up-to-date information regarding ongoing studies/trials they’re involved with at any given time.
What happens if an individual fails to submit an updated version of FDA Form 1572?
A ) They will not receive funding for their research project
B ) Their research project may not pass inspection from regulatory authorities
C ) They may face legal repercussions from regulatory authorities
D ) All of the Above
Answer: D). All of The Above Explanation: If an individual fails to submit an updated version of FDA Form 1572 then they can face various consequences such as not receiving necessary funding for their research project; having their research project fail inspection upon review by regulatory authorities; or facing legal repercussions from said authorities due its importance in providing complete documentation related to ongoing studies/trials involving human subjects which helps protect participants’ rights while conducting necessary research work safely and ethically within regulatory guidelines set forth by law enforcement bodies responsible for protecting public health around world according these standards set forth through years long process establishing best practices medical community has come accept today across many countries globally depending respective jurisdiction laws apply under question particular case being consider review possible action taken based findings presented within scope parameters policy established maintain highest ethical standard ensure well-being everyone involved
CCRPs provides principal investigator certification to ensure accuracy and efficiency for form completion and compliance.