WHAT IS INVESTIGATORS STATEMENT FORM ( FDA FORM 1572) ? WHICH COUNTRIES REQUIRES FORM 1572

Investigators are backbone of clinical research, since they are the one responsible for providing interventions to research subjects and taking data of treatment response. 

"Investigator means an individual who actually conducts a clinical investigation  i.e. under whose immediate directions, investigation is conducted by a team of individuals. the investigator is the responsible leader of the team."  (21 CFR 312.3) 

sometimes investigator is called principle investigator when study being conducted by group of peoples and he is the team leader. 

the statement of investigator form also called FDA FORM 1572, must be completed, signed and dated by principle investigator before study begins. the investigator submits it to sponsor and sponsor finally submitted to regulatory authority i.e. FDA. 

here is the content of FDA form 1572: 

• name and address  of the investigator
• title of the protocol, including the IND number
• name and address of the facility where the  research will be conducted
• name and address of any clinical laboratories that will be used
• name and address of  IRB used to approve the study 
• name of any sub investigator who will be associated with the study
• investigator commitment section

there is also a section of the form 1572 that lists responsibilities of  investigators. these include a commitment by the investigator that he or she will: 

• conduct the study according to the protocol
• comply with the regulations
• personally conduct or supervise the trial
• obtain informed consent from subjects
• report adverse events properly
• read and understand the material in the investigator brochure before stating the trial
• assure that others people assisting in the trial are aware of their obligations. 

signing by investigator in form 1572 is a legal binding commitment has been made to conduct a study according to the regulation and constrains of the  form 1572. 

Form 1572 is enforced by food and drug administration US, and is confined to them. similar agreement happens at the time of clinical trial agreement (CTA) in rest of  countries.  

THREE PILLARS OF CLINICAL TRIAL: SPONSOR, INVESTIGATOR AND SUBJECT

Clinical trial is an essential platform for testing efficacy and safety of any medicinal product, device or agents in human for the purpose of marketing in future. Any medicine should go through different phases of clinical trial before getting approval from regulatory authority for marketing by using healthy as well as targeted diseased human subject as volunteers. 

Development of a drug from any of potential compound detected on laboratory is a complex process which requires series of investigations, testing and trial by considering regulatory and ethical aspects. Total estimated timing new drug development is 12 to 15 years and estimated costs of 3.5 billion USD. here we discuss three major  and participating aspects as three pillars of clinical trial, which are sponsor investigator and subjects. 

1. sponsor:                                                                                                      Sponsor can be any person, organization or manufacturing company itself who initiates trial by selecting potential investigating site and investigator based upon area of expertise, quality controls by routine monitoring and auditing, owns all financial aspects through the process and acts as point of contact in case demanded by higher authority. 
2. investigator :                                                                                                      Investigators are doctors by profession who directly conduct study in human by taking medical decision of trial subject, giving intervention or investigational product, recording all clinical and laboratory evidences, management of any emergency situations and maintaining all record. In short, investigator is responsible for every activity within trial site. Investigators are selected by sponsor 

1. subjects:                                                                                                                      Subjects are those individuals who participate in clinical trials voluntarily by signing on informed consent form. Voluntariness of participants after being informed foreseeable risks and benefits is the key factor before initiating any interventions and should not be compromised. Institutional ethics committee is that body which takes responsibilities of protection of right, safety and well beings of human subjects, which gives approval/favorable opinions to conduct study after going in detail through protocol, investigator’s brochure, curriculum vitae of investigators, other documents related to data entry and analysis  for more information related to this topics with different prospective, go through following links .https://www.jstor.org/stable/pdf/25386081.pdf   https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2028034/

WORLDWIDE REGULATIONS OF GMP, INITIATION AND APPLICATIONS

If GMP is not followed, drug is adulterated

     

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     Compliance with GMP is a necessary condition for marketing authorization, in other words domestic and foreign producers of pharmaceutical companies cannot sell or market their drugs without it in the West and North. There is no stage of drug life cycle which is not regulated and documented whether it is the laboratory phase of a new molecular entity discovery, testing in clinical trials, or the licensing, manufacturing, and distribution. according to new industry standards, Drugs are considered to be adulterated, if GMPs are not met. here we discuss about worldwide regulations for GMP, how it initiated and applied. 

•   First version of GMP guidelines for manufacturing, processing, packing, or holding finished      pharmaceuticals was introduced by US FDA in 1963 

•   Four years later, the WHO version of GMPs was prepared by a group of consultants at the         request of the Twentieth World Health Assembly (WHO 2004). From then, there were several   amendments and extensions of the guidelines and many countries developed their own GMP   guidelines which are based on the WHO guidelines. 

•   ln   1991, GMP standards were harmonized at the EU level.
•     ln 1999, the  lnternational Conference on Harmonization, a common project of the EU, Japan and the US,  brought GMPs for Active Pharmaceutical Ingredients, which apply in signatory countries, the EU,  Japan and the US, and also in other countries (e.g., Australia, Canada, Singapore).

       The enforcement of GMPs rests on individual states: in the US, the responsibility is                      with  National Regulatory Agencies. 

                                                                                                                                                                  

 

10 Principles that needs to be followed for having good manufacturing practice.

GMP which stands for good manufacturing practice is a systematic process approach for ensuring that the products produced in industries are consistently produced and controlled according to quality standards. It is mainly designed to minimize the risks involved in any drug or food production that cannot be eliminated through testing the final product.  here  i have mentioned 10 Principles that needs to be followed for having good manufacturing practice.

1. Writing steps by steps operation procedures and work instructions.
2. Carefully following written procedures and instructions to prevent contamination, mix-ups and errors.
3. Properly and accurately documenting work for compliance and traceability. 
4. Proving the systems doing they are design to do by validating their work.
5. Integrating productivity, product quality and employee safety into the designing and construction facilities and equipment.
6. Properly maintaining facilities and equipment.
7. Clearly defining, developing and demonstrating job competence.
8. Protecting products against contamination by maintaining cleanliness sand hygienic in daily life.
9. Bringing quality into product by systematically controlling components and product related process such as manufacturing, packaging and labeling, testing, distribution and marketing.
10. Conducting planned and periodic audits for compliance and performance.