Frequently asked questions statement of investigator form fda 1572 guidance for sponsors, clinical investigators, and irbs may 2010. The statement of investigator, form fda 1572 1572, is an agreement signed by the investigator to provide certain information to the sponsor and assure that heshe will. Fda does not require submission of a paper copy for electronic submissions submitted using the fda esg. The advanced tools of the editor will direct you through the editable pdf template. If using a paper copy of the form, rather than an electronic form, the form fda 1572 ideally should be. Information and guidance sheet for the completion of the. Fda form 1572 top of page 1 this is where an individual pi is listed. Investigators are not required to submit a 1572 to cgirb, even when one is required.
Form fda 1572 statement of investigator free download. Food and drug administration fda code of federal regulations for the clinical trial. Instructions for completing an investigational product destruction form a separate form is required for each network or consortium, protocol, site and investigator. According to dma, an investigator in denmark cannot comply with the requirements in the 1572 form, therefore the investigator should not sign 1572 form. All sections of the form fda 1572 must be completed. Form fda 1572 and the expired version is the only one available on the website, it is acceptable to use the expired form. Once completed you can sign your fillable form or send for signing. Statement signed by the investigator provides information to the sponsor often referred to simply as a 1572 assures the investigator will comply with fda regulations related to the conduct of a clinical investigation of an investigational drug or biologic. The use of the form 1572 is probably overdone in industry. Copies of form fda 1572 with its attachments may be sent by the sponsorinvestigator to fda to satisfy form fda 1571, box 12, item 6 bd. Make a photocopy of the form fda 1572 and file it with the essential regulatory documents. They should also include a statement of commitment on an alternate, signed form or on the protocol signature page.
Form 1572 is routinely used as the vehicle of choice to accomplish some of this documentation. Revisions to the form fda 1572 may be made whenever there is. The following summary provides highlights of key points found in the may 2010 procedural. The form 1572 untitled form is 2 pages long and contains. Food and drug administrations fdas form fda 1572 is one of the many important regulatory documents submitted to the agency in connection with clinical trials. The statement of investigator, form fda 1572 1 572, is an agreement signed by the investigator to provide certain information to the sponsor and assure that helshe will comply with fda regulations related to the conduct of a clinical investigation of an investigational drug or. Communications sponsor correspondence cro correspondence monitoring log c. Parents are not required to sign the assent form that is signed by the child. Op 2 dfhcc operations for human research completion of form. Forward the original signed form fda 1572 to the sponsor or government agency as applicable.
The por should retain copies of the signed, approved investigational product destruction form in the pharmacy files. Op 2 dfhcc operations for human research completion of. In july 2008, fda released a draft guidance to answer frequent questions about form fda 1572, also called the statement of investigator form. Us therefore there is no requirement for fda forms 1572 to be signed. On june 21, 1997, wilson signed fda form 1572, in which he agreed to conduct the study in accordance with the investigational plan and applicable federal regulations. Enter your official contact and identification details. Each pi is responsible for designating qualified subinvestigators at their site, who will be listed on the form fda 1572. Always confirm the most current form is being used by accessing the form on the fda web site using the link provided above. Department of health and human services form approved. The statement of investigator, form fda 1572 is an agreement one. Form fda 483, inspectional observations, is a form used by the fda to document and communicate concerns discovered during these inspections.
Ind filing, timelines, paperwork and reports september 3, 2010. If the trial results are to be used for a us submission, then the trial must be. Can regulatory documents, such as the form fda 1572 and the financial disclosure forms, be signed and scanned in for the internal files. Statement of investigator form fda 1572 may 2010 procedural this guidance describes how to complete the statement of investigator form form fda 1572. Fda form 1572 and nonus clinical trials to complete or. Fill out, securely sign, print or email your form fda 1572 pdf food and drug administration instantly with signnow. In july 2008, fda released a draft guidance to answer frequent questions about form fda1572, also called the statement of investigator form.
Form fda 1572 pdf food and drug administration fill out. Information sheet guidance for sponsors, clinical investigators, and irbs on fda form 1572, statement of investigator. A form that must be filed by an investigator running a clinical trial to study a new drug or agent. The adenovirusderived vector contained a functional otc gene. Frequently asked questions statement of investigator form fda 1572 current version of form fda 1572 form fda 1572 instructions.
When must a 1572 be updated or a new 1572 completed and signed by an. The investigator verifies that he or she has the experience and. It is a signed agreement from the investigator that heshe will conduct the research in. The legally binding nature of the signed fda 1572 form is underlined on the form itself stating that willfully false information is considered criminal offense u. Food and drug administration fda is authorized to perform inspections under the federal food, drug, and cosmetic act, sec. Inspections, compliance, enforcement, and criminal. Fda form 1572 and nonus clinical trials to complete or not to. The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the office of regional operations hfc100, 5600 fishers lane, rockville, md 20857. Fill out, securely sign, print or email your form 1572 20162020 instantly with signnow. Customary practice is a signed and dated cv but this is not required by regulation.
Scanning copies of original documents may not conflict with fda regulations if they are consider certified copies, meaning they are verified, as indicated by a dated signature, as an exact copy having all of. Definition of form fda 1572statement of investigator. The statement of investigator, form fda 1572, is an agreement, signed by the principal investigator pi, to provide certain information to the sponsor about the. At the time you signed the form fda 1572, statement of investigator, for the study, you agreed to maintain adequate and accurate records in accordance with 21 cfr 312. Fda inspection preparation guide please alert the irb upon receiving the call or letter from the fda to schedule the inspection. Persons using electronic signatures shall, upon agency request, provide additional certification or testimony that a specific electronic signature is the. Field numbers below correspond to the numbered boxes on the form fda 1571. Signed fda form 1572 with ucsd irb listed as the irb if device study copy of unredacted letter from fda granting the ide or letter form sponsor stating that the study is a nonsignificant devise study and the basis for that determination or documentation of why the investigation is exempt from ide requirements or otherwise exempt or. A downloadable pdf showing these sections more clearly is available here. Many common mistakes are made when filling out and maintaining the 1572 form, so the hope is that this guide will be useful to new sites, clinical. Investigational new drug application ind form fda 1572 pdf 208kb. Pdf form fda us food and drug administration 1572 completions and revisions generate a lot of paperwork for the pharmaceutical industry. Food and drug administrations fda s form fda 1572 is one of the many important regulatory documents submitted to the agency in connection with clinical trials.
For the purposes of form fda 1572daids ior forms, the placement of the signature in the signature section provides the meaning of the signature in agreeing to the commitments identified on the form. This is a form that accompanies the cover letter and submission. Vote summary v05005 recommends that the german investigators should preferably be involved as the nonind sites in the. For the purposes of form fda 1572 daids ior forms, the placement of the signature in the signature section provides the meaning of the signature in agreeing to the commitments identified on the form. If using a paper copy of the form, rather than an electronic form, the form fda 1572 ideally should be printed as a single, double sided sheet. Use of the fda 1572 form for clinical trials in europe. Please follow the instructions given by the study sponsor. The most secure digital platform to get legally binding, electronically signed documents in just a few seconds. It includes a list of 38 frequently asked questions encountered when completing the form. The items identified in above shall be subject to the same controls as for electronic records. There is no need to prepare and sign a new form fda 1572 when the omb expiration date has been.
Transcelerate guidance document for fda form 1572 completion. Fda documentation7 signed and dated original application and all subsequent submissions e. The form 1572 somehow develops a life of its own with constant updates, signatures, changes, etc. Fda form 1572 and nonus clinical trials to complete or not. Revisions to the form fda 1572 may be made whenever there is a change to the information for any section. The 1572 itself declares that, no investigator may participate in an investigation until heshe provides the sponsor with a completed, signed statement of investigator, form fda 1572. The statement of investigator, form fda 1572, is an agreement signed by the principal investigator pi to provide certain information to the sponsor and assuring that heshe will comply with fda regulations related to the conduct of a clinical investigation of an investigational drug or biologic. The danish medicines agency dma has published an article about whether or not fda 1572 form should be signed by the investigators outside us in a multinational trial. Name and address of investigator name of clinical investigator address 1 city address 2 stateprovinceregion country zip or postal code 2. No investigator may participate in an investigation until heshe provides the sponsor with form fda 1572 21 cfr 312. Each pi is responsible for the oversight and conduct of research at their dfhcc institution.
Information can be supplied in the form of attachments such as a curriculum vitae rather than entering that information directly onto the form, but this should be so noted under the relevant section numbers. Fda form 1572 fill out and sign printable pdf template. Definition of form fda 1572statement of investigator nci. Form fda 1571 form fda 1572, all versions cvs for pi and subinvestigators listed on all versions of form fda 1572 b. Fill out, securely sign, print or email your this report and the summary report table are to be completed by the applicant when submitting a 510k that references a national or international standard instantly with signnow.
This single activity generates a lot of paper and submission work. Some sponsors have created an alternate form based on the 1572 without the fda references or ind commitments. Frequently asked questions statement of investigator. Final cdeg recommendation on use of form fda 1572 for. A food and drug administration guidance is nonbinding, but it does serve as useful information on how to interpret the agencys regulations. The sponsor should collect the 1572 information from the nonind sites. Important information about digitalelectronic signatures. Form fda 1572 pdf food and drug administration fill out and. Start a free trial now to save yourself time and money. Also referred to as form 483 or merely 483, it states thereon that it. The statement of investigator, form fda 1572 is an agreement onesided.
Zip or postal code address 2 country name of clinical investigator address i. Use a check mark to point the answer wherever required. The vector was rendered incapable of replicating by the. No investigator may participate in an investigation until heshe provides the sponsor with a completed, signed statement of investigator, form fda 1572 21 cfr 312.