STATEMENT OF INVESTIGATOR
STATEMENT OF INVESTIGATOR
Introduction:
It is a form which has to be signed by investigator to provide all the necessary information to the sponsor and it is also a documented evidence that shows investigator should know all the FDA regulations and he/she is qualified, experienced and trained to conduct clinical investigation for an IND or any other biologic product. Investigator statement is also known as Form 1572.
Importance of Form 1572
Investigator statement (Form-1572) contains following information:
1. Name and address of the investigator
2. Name and code number of the protocols that was followed by investigator in studies of investigational new drug
3. The name and address of the investigation site i.e medical school, hospital organization and information about research centre where clinical investigation carried out.
4. Name and address of clinical laboratory and other information related to clinical facilities which is used in clinical investigational studies.
5. Name and address of IRB/IEC, these boards are responsible for doing review and approves clinical studies.
Apart from these an investigator statement also contain responsibilities of investigator that has to be followed during clinical investigation.
1. The investigator whether he/she should follow the protocol which was given by sponsor, he/she are only eligible to change anything in the protocol after sponsor, except when it comes to subject safety and protection.
2. The investigator should obey with all requirements regarding the responsibilities of clinical investigators and all other pertinent requirement in this part.
3. He/she personally conduct and supervise the described investigations.
4. He/she should explain the subjects that what drug they are taking for the clinical investigation and he/she should clearly explain the inform consent form to the subjects and he/she must obey IRB/IEC.
5. He/she will report the serious adverse event that occur in between of the trail to sponsor in accordance with 312.64.
6. He/she should read and understand the investigator brochure, which includes risk and benefits of the IND
7. Investigator will ensure that all associates, colleagues and employees assisting in the conduct of the studies are informed about their obligation in the meeting the above commitments.
8. A commitment by the investigator that, for an investigation subject to an institutional review requirement under part 56, an IRB that complies with the requirements of that part will be responsible for the initial and continuing review and approval of the clinical investigation and that the investigator will promptly report to the IRB all changes in the research activity and all un anticipated problems involving risks to human subjects or others, and will not make any changes in the research without IRB approval, except where necessary to eliminate apparent immediate hazards to the human subjects.
9. Investigator form also contains information related to sub investigators who involve in the study at clinical trial site.
Other than this Form 1572 also includes information related to investigator qualifications, experience and protocols that are followed by the investigator during the clinical investigation.
Curriculum vitae: It is a documented evidence which provides whether the investigator is qualified, trained or experienced for the conduction of clinical study.
Clinical Protocol:
(i) For phase 1investigation, a general outline of the planned investigation which includes timeline of the study and maximum number of subjects to be involve.
(ii) For Phase 2 or 3 investigation, an outline of the study protocols which provides data like number of subjects are going to treat with drug and number of subjects take control and other information like characteristic of subjects by age, sex and other clinical observation and based on lab tests.
Statement of investigator also contain financial information to allow the sponsor to submit complete and accurate certification or disclosure statements required under part54 and commitment from the clinical investigator to update the information and any changes occur during clinical study
Common audit findings
Submission of incorrectly completed forms.
Missing submission of requested documents in Section 2, especially when study personnel have been added to the 1572 or in cases when the original PI has been replaced.
Failure to submit updated 1572 forms to both IRBs and sponsors.
Site not having CVs for all study personnel listed on the 1572 form.
Site lacking copies of current medical license for the PI.
Upon collecting CVs that are not specific templates, it very important to be mindful of data privacy issues and make sure no sensitive information is listed on study personnel CVs, such as Social Security numbers, family members’ information, etc.
CVs provided are not current within the last two years.
Missing documentation within the Principle Investigator’s CV of his/her affiliation with the site conducting the clinical trial.
What information we can get Form 1572
The main aim of Form FDA 1572 is to make commitment with principle investigator to conformance with FDA regulations prior to drug shipment to clinical research sites.
This commitment is very genuine, and each Principle Investigator shall clearly and carefully read the form 1572 before doing sign on it.
Each Sponsor or delegated CRO should do IND shipment after satisfying with a signed Form 1572 received in-house.
IRB requirements must be fulfilled before starting the study and any changes during a clinical trial should be documented at the research site and same thing should submit to Sponsor.
The use of the Form 1572 is probably overdone in industry. This single task generates a lot of information.
Finally the Form 1572 somehow develops a life of its own with constant updates, signatures, changes, etc., and other information such as the obtaining of Financial Disclosure information.
References:
1. 21 CFR 312.53 (c) (1). Investigational New Drug Application; Responsibilities of Sponsors and Investigators; Selecting Investigators and Monitors; Obtaining Information from the Investigator. 1 April 2004. http:// www.fda.gov/oc/gcp/regulations.html [5 January 2005].
2. 21 CFR 54.2 (d) and 54.4. Financial Disclosure by Clinical Investigators. 1 April 2004. http://www.fda.gov/ oc/gcp/regulations.html [5 January 2005].
3. 21 CFR 312.53 (c) (4). Investigational New Drug Application; Responsibilities of Sponsors and Investigators; Selecting Investigators and Monitors; Obtaining Information from the Investigator. 1 April 2004. http://www.fda.gov/oc/gcp/regulations.html [5 January 2005].
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