What Is An Investigator Initiated Study?

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What Is An Investigator Initiated Study
What are investigator-initiated studies? – IISs are clinical studies initiated and managed by a nonpharmaceutical company researcher/s who could be an individual investigator, an institution or a group of institutions, and a collaborative study group or a cooperative group.
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What is an investigator study?

(in-VES-tih-gay-ter) In research, a person who is involved in running a clinical trial or research study. The investigator may help prepare and carry out the protocol (plan) for the study, monitor the safety of the study, collect and analyze the data, and report the results of the study.
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What is investigator initiated trials FDA?

An IIT is defined as a study with scientific and medical merit developed and sponsored by an independent Investigator or academic sponsor. An IIT is a clinical study conducted without the participation of Novartis, for which the IIT sponsor requests Novartis to provide either funding, drug product or both.
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What is an investigator initiated trial in pharmacovigilance?

Investigator initiated trials (IITs) Why this editorial on IITs? Are such trials truly initiated by investigators? Are these trials initiated by industry? Is there a need for such trials to complement industry initiated trials? In the recent past, industry has been collaborating with academia to facilitate investigator initiated trials.

  1. Ethical research-based companies have written standard operating procedures (SOPs) on IITs.
  2. Clinical investigators may wish to perform clinical trials with or without company drugs within or outside the approved product license or prior to marketing authorization.
  3. Companies may consider requests to support such trials pre- and post-first marketing authorization.

The company may be willing to support these studies without taking the role of sponsor as defined by the International Conference on Harmonization (ICH)-Good Clinical Practice (GCP). Support from the company may be in the form of drug product, comparator drug, financial resources or all mentioned.

  • Clinical trials proposed upon the initiative of clinical Sponsor-Investigators and without the company taking the role as a sponsor are termed Investigator Initiated Trials.
  • What is driving the need for IITs? Clinical trials are not, and cannot be, designed to determine all the potential uses for a medication.

IITs expand product knowledge, including safety. Physician researchers often identify new ways of using existing treatments, thus improving the health of numerous other patients. And there is always greater weight attached to non-industry sources of data.

Even large pivotal randomized clinical trials are done by academic research organizations, e.g., Public Health Research Institute (PHRI) or Duke Clinical Research Institute (DCRI). On the face of it we must have more investigator initiated trials. The usual practice is to design global clinical development programs (with the help of researcher-clinicians) and then place studies in countries where carefully selected investigators execute the study under the oversight of clinical operations.

The principal investigator is sometimes reduced to being a pure implementer. At least those clinicians who participate in protocol development meetings get the satisfaction of being a part of cutting edge research and not merely being the executors. But the evidence from such gold standard prospective, randomized, double blind, controlled clinical trials, while it may help prove the efficacy of the drug and garner marketing authorization approval, may need to be complemented by studies done by doctors in the real world.

  1. The former is limited in extrapolation or generalizability and therefore the other RCT or the Real world Clinical Trial needs to be initiated.
  2. Of course, IITs can also be done pre-marketing, e.g., in a phase IIIb setting.
  3. While companies do conduct such phase IV studies, it is also good if investigators initiate their own research in the post-marketing environment.

In some cases it is part of a company’s strategy to expand information around the product and/or therapeutic area. Some IITs are in scope and some are not in scope from the company’s perspective. Whether data from IITs, funded by a company, can be used for regulatory submissions to get new indications approved is a matter of debate since these studies are generally not monitored by the company per its SOPs.

There are some important caveats. The trial request must be initiated by the investigator and not by the company. It has to be a spontaneous, unsolicited request. The same needs to be directed to the medical department. The request, in the form of a concept note, is evaluated based on objective criteria such as credentials of the investigator (Curriculum Vitae showing s/he has designed and conducted original research; not black-listed), need for such a study (meets unmet medical need or fills a gap in medical literature), quality of design of the study, and cost-effectiveness (needs to be reasonable enough to fit into the budget).

Whether the company will benefit from the study or whether it involves the product or therapeutic area or whether the investigator is important to the company should not be criteria for approval. Scientific rationale, study design, endpoints, formulation, statistics, budget and availability of local human and financial resources as applicable to oversee and support the study should be the criteria for approval, and compliance with ICH-GCP or local GCP regulations and all laws, rules, guidelines and regulations applicable to the planned IIT, including local, anti-corruption, anti-bribery and anti-kickback laws.

Once a go/no go decision is reached, based on the above criteria, the same is communicated to the investigator. Hence expectations need to be managed upfront. If yes, then a protocol template may be sent to the investigator who is then expected to flesh out the concept note into a full-fledged protocol.

The same is again reviewed locally by the medical department, and sent to the regional and global medical team for further inputs into the scientific aspects. Funding of the study is generally done by the local affiliate, though in some cases the global team may also fund.

  1. Once approved/rejected, the same is communicated back to the investigator.
  2. If yes, then s/he is expected to be trained on Adverse Event reporting, and other aspects of Good Clinical Research Practice,
  3. An official agreement is signed between the investigator and company and s/he may receive milestone payments.

The investigator is expected to take the study all the way to publication (the researcher is not mandated to share the manuscript with the company) and update CTRI accordingly. In such studies there is no indemnification of the investigator or insurance of the patient by the company.

  1. The company only funds the investigator.
  2. All other liability rests with the investigator as outlined in the agreement.
  3. The investigator is expected to follow the law of the land (e.g., inclusion of the compensation clause in the informed consent form).
  4. In case a patent or data exclusivity may arise out of data generated from the study, the investigator has the right to decide whether s/he wishes to share the same with the company.

Some companies have an agreement with the investigator on co-sharing of patent holder rights. Similarly, the data may be submitted to the regulator in support of a new indication for a product. In such cases it is a different agreement (as with the patent case) and now the company does share liability and may decide to monitor such a study.

Such IITs do serve to add to the body of generalizable evidence and advance medical science. It need not have anything to do with the company or its products or therapeutic area. Of course IITs can also be funded by non-industry, academic bodies or the government. There is always skepticism if industry funds any research though even in industry-sponsored studies, ultimately it is the investigators’ study as the data is of their patients, they have full access to the raw data, they review and approve the study report and publication.

So whose study is it anyway? One example of a large IIT is the Anglo Scandinavian Cardiac Outcomes Trial (ASCOT). A good idea would be to simply fund an academic body such as the European Association for Study in Diabetes (EASD) which writes and updates guidelines.

If one reads guidelines one does come across areas where research is needed to answer hypotheses. Such research can be funded by industry although it may have nothing to do with their products. Thus one has more of evidence-based medicine and less of opinion- or eminence-based medicine. Industry (I) could come together with Academia (A) and set up an Institute of Real World Research (R) which can fund such IITs thus also clearing the AIR of misperceptions and increasing transparency.

Competitors could collaborate with each other and facilitate practical or pragmatic clinical trials and comparative effectiveness research. It is not that one drug is better than another. The real issue is no longer the choice of the “best” agent, but rather the identification, on a rational basis, of the population of patients who will benefit from a given agent the most.

In practice when a doctor sees every patient s/he is in effect doing a clinical trial. It is time to do research in practice and contribute to clinical development and research. It is time to inculcate that mindset of inquiry into observations in practice and have the hunger and thirst of trying to find answers.

It is time to make time for truly investigator-initiated trials and not merely industry-initiated trials. The thoughts are those of the author in his personal capacity and not as the medical director of the company he is currently employed with.1. International conference on harmonization of technical requirements for registration of pharmaceuticals for human use.

  • ICH harmonized tripartite guidelines.
  • Guidelines for GCP E6.1996 Jun 10; 2.
  • Lastersky J.
  • Antifungal therapy in patients with fever and neutropenia – more rational and less empirical.
  • N Engl J Med.2004; 351 :1445–7.3.
  • Chen DT, Miller FG, Rosenstein DL.
  • Clinical Research and the Physician-Patient Relationship.
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Ann Intern Med.2003; 138 :669–72.4. Miller FG, Rosenstein DL. The Therapeutic Orientation to Clinical Trials. N Engl J Med.2003; 348 :1383–6. : Investigator initiated trials (IITs)
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What is an investigator sponsored study?

Clinical trials take place all over the world, in hospitals, universities, doctors’ offices, and community health clinics. They can take years to plan and execute, and, as we have mentioned in past articles, many organizations and individuals come into play along the way.

The study sponsor is the party funding the research, so research can generally be divided into 2 groups, according to the type of sponsor. Trials sponsored by pharmaceutical biotech or medical device companies are called industry-sponsored trials. In an investigator-sponsored trial (IST), the sponsor is not a commercial entity, but rather a clinical investigator, or, in the case of retinal clinical studies, a retinal specialist.

These trials provide pivotal contributions to clinical research and development and to advancing medical and scientific knowledge. Who is an investigator sponsor? A study sponsor is “a person who takes responsibility for and initiates a clinical investigation.” 1 In an IST, the sponsor is “an individual who both initiates and conducts an investigation and under whose immediate direction the investigational drug is administered or dispensed.” 1 The criterion is that the investigator-sponsor plans, designs, and conducts the investigation and must comply with the requirements of both the investigator and the sponsor.
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What is an example of investigative study?

Every IT Industry uses different types of investigative research methods to help better understand the issues of management and organizational levels. As a part of investigative research, two different types of methods are performed: Quantitative and Qualitative.

  • This is one of the professional practices as per industry standards adopted by an IT Industry.
  • This type is research is done in various domains and with different type of methodologies depending on the type of organization.
  • The basic cause for the development of quantitative research methods is to study natural phenomena.

Quantitative research is performed in the form of survey methods, science experiments, numerical analysis like mathematical modelling and formal methods like Econometrics, On the other hand, qualitative research methods were developed to study social and cultural phenomena.

Our IT assignment help experts also follow the same approach. Qualitative research in IT domain is performed by researchers with the help of qualitative data like observation of behavior of people during fieldwork, interviews, action research, written questionnaires, documents, case studies, ethnography and the researcher’s thought process and reactions.

Due to the absence of interviewer there are no possibilities of interviewer bias The inspiration for performing qualitative research, as against quantitative research, comes from the ability that differentiates human beings from the rest of the natural world.

This ability is – the ability to “talk”. Qualitative research methods are designed in such a way to aid researchers in understanding people and the impact of society and culture on them. In the year 1994, the two researchers: Kaplan and Maxwell argued that the aim of understanding a subject from the eyes of the participants and their social and cultural context is mostly lost when of textual data gets quantified.

There are ample means to acquire information in IT Industry. Some of the common ways investigative research methods are literature searches, communicating with people, focus group discussion, personal interviews, telephonic surveys, electronic mail surveys, mail surveys, and internet surveys.
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What are the benefits of investigator initiated trials?

Benefits to Industry and Researchers – IITs can provide several advantages to both the researcher and the company:

  • Gain more information on product safety and efficacy
  • Answer questions that clinicians face in a real word setting in their practice
  • Non-industry sources of data improve the credibility of data generated by the company
  • Generation of new ideas and intellectual property

In summary, ITTs help fills knowledge gaps that have not yet been addressed. The overall result is a significant improvement in the clinical outcomes of products that will come to market or further enhance those that are already marketed.
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What does PI mean in FDA?

Who is the Audience for This Webpage? – FDA’s Prescribing Information (PI) resources on this webpage are primarily directed to industry staff who develop PI. For other prescription drug * labeling resources for industry such as those for FDA-approved patient labeling, carton and container labeling, generic drug labeling, biological product labeling, labeling databases, and product databases visit FDA’s Labeling Resources for Human Prescription Drugs,

If you are a healthcare professional, patient, or caregiver, visit Frequently Asked Questions about Labeling for Prescription Medicines, FDA-approved Prescribing Information (PI), also known as United States Prescribing Information (USPI), reflects FDA’s finding regarding the safety and effectiveness of the human prescription drug under the labeled conditions of use.

The PI is written for the healthcare professional and must:

  1. Contain a summary of the essential scientific information needed for the safe and effective use of the human prescription drug,
  2. Be informative and accurate and neither promotional in tone nor false or misleading, and
  3. Be updated when new information becomes available that causes labeling to become inaccurate, false, or misleading.

Biologics License Application (BLA) and New Drug Application (NDA) holders should review their Prescribing Information (PI) at least annually for outdated information. When new information becomes available that causes the PI to become inaccurate, false, or misleading, the BLA and NDA holder must update the PI.

Additionally, when new data or information becomes available that could affect prescribing decisions or the clinical management of patients receiving the drug, BLA and NDA holders submit proposed revised PI (containing the updated data or information) to FDA. The Prescribing Information (PI) has two formats: “Physician Labeling Rule” (PLR) format and “old” (non-PLR) format.

Given that all new human prescription drugs approved since June 2001 and certain human prescription drugs approved before June 2001 (e.g., those approved for new uses after June 2001) must have PI in PLR format, this webpage focuses on providing resources for the development of PI with PLR format labeling.

  1. Represents a more useful and modern approach for communicating accurate and up-to-date information on the safe and effective use of drugs,
  2. Reduces the number of adverse reactions resulting from medication errors due to misunderstood or incorrectly applied drug information, and
  3. Makes PI more accessible for use with electronic prescribing tools and other electronic information resources.

Key features of PLR-formatted labeling include having a concise summary of critical information (Highlights of Prescribing Information), including a Table of Contents, ordering information according to clinical importance, and including standardized numbered sections and subsections in the Full Prescribing Information.

  • 21 CFR 201.56 : General requirements on the content and format of PLR format labeling and “old” format (non-PLR) labeling
  • 21 CFR 201.57 : Specific requirements on content and format of PLR format labeling for human prescription drugs
  • 21 CFR 201.80 : Specific requirements on content and format of “old” format (non-PLR) labeling for human prescription drugs
  • Physician Labeling Rule (PLR) : Final rule revised the content and format of Prescribing Information (PI) for human prescription drugs (January 2006)

FDA Guidances and MAPPs

  • Guidances : FDA guidances that contain recommendations for the Prescribing Information are listed by Prescribing Information section below. For example, guidances that have dosage- and/or administration-related content are included under the heading: “2 Dosage and Administration”. Alternatively, to find these FDA guidances, refer to this page.
  • Manual of Policies and Procedures (MAPPs) : Center for Evaluation and Research (CDER) MAPPs that contain directives to CDER staff to document and disseminate Prescribing Information-related policies and procedures are listed by Prescribing Information section below. Alternatively, to find these CDER MAPPs, refer to this page.

Other FDA Guidances with Prescribing Information Content

  • Best Practices in Development Proprietary Names for Human Prescription Drug Products ( final guidance )
  • Cross Labeling Oncology Drugs in Combination Regimens ( final guidance )
  • Implementing the PLR Content and Format Requirements ( final guidance )
  • Medical Product Communications That Are Consistent With the FDA-Required Labeling – Questions and Answers ( final guidance )
  • Consider using the enclosed Sample Prescribing Information Template when developing PLR formatted labeling (e.g., PLR-converting “old” format labeling or revising approved PLR format labeling). This sample template does not contain all PLR format and content regulatory requirements or guidance recommendations. Ensure that the PLR formatted labeling meets all regulatory requirements (e.g., 201.56(a) and (d) and 201.57). Refer to the Prescribing Information menu on this webpage for additional resources for development of PLR formatted labeling.
  • Final Labeling Check of Labeling Format and Appearance (2019 presentation and video )
  • Final Labeling Format Check Prior to End-of-Cycle Labeling Submission ( 2017 presentation )
  • Selected Requirements of Prescribing Information (SRPI) : A 41-item, drop-down checklist of important format elements of the Prescribing Information (PI) based on regulations (21 CFR 201.56 and 201.57 ) and guidances
  • Ashraf, Adrita; Brodsky, Eric; Burkhart, Keith. Use of Natural Language Processing Text-Mining to Identify Differences in the OVERDOSAGE Section of Drug Labeling. https://www.fda.gov/media/148926/download
  • Balogh EP, Bindman AB, Eckhardt SG, Halabi S, Harvey RD, Jaiyesimi I, Miksad R, Moses HL, Nass SJ, Schilsky RL, Sun S, Torrente JM, and Warren KE. (2019). Challenges and Opportunities to Updating Prescribing Information for Longstanding Oncology Drugs. The Oncologist, 24:1–7. https://theoncologist.onlinelibrary.wiley.com/doi/10.1634/theoncologist.2019-0698
  • Gassman, A. L, Nguyen, C.P., and Joffe, H.V. (2017). FDA Regulation of Prescription Drugs. The New England Journal of Medicine, 376: 674-82. https://www.nejm.org/doi/10.1056/NEJMra1602972
  • Guinn, D., Madabushi, R., Wang, Y., Brodsky, E., Zineh, I., and Maxfield, K. Communicating Immunogenicity-Associated Risk in Current U.S. FDA Prescription Drug Labeling: A Systematic Evaluation. Ther Innov Regul Sci (2020). https://doi.org/10.1007/s43441-020-00161-z
  • Kluetz PG, Keegan P, Demetri GD, Thornton K, Sul J, Kim J, Katzen H, Burke LB, Harvey RD, Alebachew E, Agrawal S, Nair A, Donoghue M, Pierce WF, Shord SS, Gao JJ, Pazdur R. FDA Oncology Center of Excellence Project Renewal: Engaging the Oncology Community to Update Product Labeling for Older Oncology Drugs. Clin Cancer Res.2021 Feb 15;27(4):916-921. doi: 10.1158/1078-0432.CCR-20-3213. Epub 2020 Nov 30. PMID: 33257426. https://clincancerres.aacrjournals.org/content/clincanres/27/4/916.full.pdf
  • Harrison, N.R., Sheehan, S M., Tran, M.T., Herndon, J, Brodsky, E. and Grillo, J.A. Enhancing the Accessibility and Utility of Drug Interaction Information in Prescription Drug Labeling. Duke Margolis Workshop Summary, December 2021. Available at https://healthpolicy.duke.edu/publications/enhancing-accessibility-and-utility-drug-interaction-information-prescription-drug
  • Sullivan, H.W., Squire, C., Aikin, K.J., Tzeng, J., Ferriola-Bruckenstein, K., Brodsky, E., Trentacosti, A.M., & Johnson, M. (in press). Physicians’ use of and preferences for FDA-approved prescribing information. Research in Social and Administrative Pharmacy. Available at https://www.sciencedirect.com/science/article/pii/S1551741121002862?via%3Dihub
  • Tran, MT, Grillo JA. Translation of drug interaction knowledge to actionable labeling. Clin. Pharmacol. Ther.105, 1292– 1295 (2019) https://ascpt.onlinelibrary.wiley.com/doi/full/10.1002/cpt.1427?af=R
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What is the difference between sponsor and investigator in clinical trials?

The difference between sponsors and investigators | 2001-10-01 | AHC By J. Mark Waxman, JD General Counsel CareGroup Healthcare System, Boston IRB administrators and committee members may use the words sponsor and investigator interchangeably, but it’s important to know the difference between the two.

  • A sponsor is the entity or person who takes the responsibility for a clinical investigation.
  • The sponsor may be, but is not required to be the investigator — the individual who actually conducts the clinical investigation.
  • According to the U.S.
  • Food and Drug Administration (FDA), a clinical investigation means any experiment that involves a test article that either is subject to the prior submission requirements of the FDA (found in sections 505 or 520 of the FDC Act), or is not subject to submission, but the results of which are intended to be submitted later or held for inspection as part of an application for a research or marketing permit (21 CFR section 50.3c).

In general, any clinical investigation that must meet the requirements for prior submission is subject to IRB review. An experiment is any use of a drug except for the use of a marketed drug in the course of medical practice. Finally, it is interesting to note that the actual definition of research itself is defined elsewhere to mean a systematic investigation develop to defeat or contribute to generalizable knowledge (45 CFR section 46.102d).
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What is an investigator meeting in clinical trials?

myClin In a business niche as highly critical, closely scrutinised and heavily regulated as pharmacovigilance it remains a puzzle why clinical development organisations struggle so often with the “end of process task” of distributing Safety Reports*.

  1. Site reports Serious Adverse Reaction (SAR) within 48 hours.
  2. Sponsor determines if SAR is unexpected or not.
  3. Sponsor reports SUSAR to relevant regulators within days (for EMA within 7 days and typically 15 days for the FDA).
  4. In parallel to step 3 the sponsor has a responsibility to promptly inform other sites once the matter is identified as a safety issue. While there is some scope for interpretation here, “promptly” is normally interpreted as meaning a number of days and not some longer period of time. Typically sponsors will aim to distribute safety reports within 15 days.

For reference here is how the FDA explain things – p16 of FDA Guidance Safety Reporting Requirements for INDs and BA/BE Studies. What Is An Investigator Initiated Study The reality is that this end of process task sounds simple to define but it is in fact pretty complex and time critical. In addition – organisations are often so blindly addicted to using email that alternative, more dynamic and reliable means of information distribution are strangely alien and fantastical.

But why not use distribution means that allow for active information distribution, with real-time dynamic readership information? In an age where audience behaviour is closely tracked, isn’t it time you knew who has read your latest Safety Report, and more crucially who has not? An Investigator Meeting is a time for everyone involved with a new clinical trial to meet face to face and get familiar with the study, including learning about the roles in the study.

This is essential for building and maintaining solid communication throughout the entire duration of a study, as it keeps the study on a more personal level. When a sponsor initiates an Investigator Meeting, depending on the size of the company, they may look to internal staff to plan an Investigator Meeting.
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What is ICSR in clinical trials?

Description: The HL7 Individual Case Safety Report (ICSR) captures information needed to support reporting of adverse events, product problems and consumer complaints associated with the use of FDA regulated products. ICSR Release 2 was completed December 2011 as an SDO Joint Initiative Project between the International Standards Organization (ISO), the European Committee for Standardization (CEN) and HL7.

  1. Information about the SDO Joint Initiative can be found at: http://www.jointinitiativecouncil.org/,
  2. The ICSR specification, ISO/HL7 27953 is a multi-part standard created to consolidate work efforts in ISO and HL7 as follows: 1.
  3. ISO new work item proposal N545: Health informatics – Pharmacovigilance – Structure and data elements of individual case safety report (reclassified as ISO 27953); 2.

Health Level Seven (HL7) Individual Case Safety Report (ICSR) Release 1, Normative Standard; 3. HL7 ICSR Release 2, Draft Standard for Trial Use (DSTU)ISO/HL7 27953-1 (Part 1) is designed to address areas of overlap across the work items and form a messaging framework reference.

  • This framework can be applied to support data exchange requirements described in the many different use cases presented as storyboards in this International Standard.
  • This framework allows for future development work to be carried out so that additional use cases that are not currently addressed in this edition can be added in the future as new parts to this International Standard.

ISO/HL7 27953-2 (Part 2) is designed at a conformance profile for Part 1 for use by the International Conference on Harmonisation (ICH) revised guideline E2B(R3): Data Elements for Transmission of Individual Case Safety Reports. The ICH requirements have been further extended to take into account additional international requirements.

Use of ISO 27953-2 is dependent upon the related ISO vocabulary harmonization work Identification of Medicinal Products (IDMP), which is a suite of related standards used to uniquely identify regulated products through the product lifecycle (premarket to postmarket). Individual Case Safety Report Resources: FDA implementation of the Individual Case Safety Report (ICSR) Standard varies by product type.

Implementers should contact the receiving program (e.g., FAERS, VAERS, eMDR, CVM) prior to submission of ICSRs to the Agency. Links to applicable ICSR guidance documents are provided as a resource to clarify ICSR content and format requirements for electronic ICSR submissions to FDA.

Biologics and Vaccines Adverse Events Food Adverse Events Human Drugs Adverse Events Medical Device Adverse Events Veterinary Adverse Events Tobacco Adverse Events

ICSR Guidance Documents, Implementation Guides, Specifications, Schema Files, and Validation Procedures

Schema Files and Validation Procedures

Schema Files

Human Drugs, Biologics and Vaccines

Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility Guidance for Industry Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed without an Approved Application Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Postmarketing Individual Case Safety Reports Guidance for Industry: Providing Submissions in Electronic Format – Postmarket Non-Expedited ICSRs Technical Questions and Answers Vaccine Adverse Event Reporting System (VAERS) Electronic Submissions

Medical Devices

Questions and Answers about eMDR – Electronic Medical Device Reporting – Guidance for Industry, User Facilities and FDA Staff

Veterinary Products

Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine

Food and Cosmetics

Currently the Foods program is not collecting adverse event reports using the ICSR format. Please refer to the Safety Reporting Portal for further information.

Tobacvo Products

Currently the Tobacco program is not collecting adverse event reports using the ICSR format. Please refer to the Safety Reporting Portal for further information.

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What are investigator responsibilities in clinical trials FDA?

During a subject’s participation in a trial, the investigator (or designated subinvestigator) should ensure that reasonable medical care is provided to a subject for any adverse events, including clinically significant laboratory values, related to the trial participation.
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What is an investigational drug trial?

Understanding Investigational Drugs Have you ever thought about joining a clinical trial that is trying to find out if an investigational drug works in treating your disease or medical condition? Or maybe your healthcare provider has talked to you about treating you with an investigational drug through expanded access.

If the drug is safe and effective. How the drug might be used in that disease. How much of the drug is needed. Information about the potential benefits and risks of taking the drug.

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Can sponsor and investigator be the same?

A sponsor-investigator is an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. A sponsor-investigator is responsible for all regulatory requirements as both a sponsor and an investigator.
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What is an investigator-initiated grant?

These grants support investigator-initiated projects in basic biomedical research. Projects funded under these grants could lead to new or improved technologies, including reagents, instruments, devices and methodologies, algorithms, or software that can be utilized in a broad range of biomedical research. Funding Mechanisms

Focused Technology Development Research Grants (R01) support research that may involve a concept, design, fabrication, and/or test of technologies, with the overall objective of leading to more powerful and useful tools for biomedical research. The application is expected to include preliminary data that support the proposed project. Exploratory Technology Development Research Grants (R21) support research on novel concepts that have not yet been tested for feasibility. These grants reward high-risk or novel approaches with potential for significant impact. This NIGMS R21 mechanism must not have preliminary data and cannot be renewed. Maximizing Investigator’s Research Award (MIRA) (R35) provides support for a research program in an investigator’s laboratory, including technology development, that falls within the mission of NIGMS. MIRA grants are generally for five years and can provide investigators with greater stability and flexibility. Academic Research Enhancement Awards (AREA) (R15) supports biomedical research in educational institutions that provide baccalaureate training for a significant number of the nation’s research scientists but have not been major recipients of NIH support. This award enables qualified scientists to receive support for up to 3 years for small-scale research projects. Support for Research Excellence (SURE) Program (R16) develops and sustains research excellence of faculty investigators and provides students with research opportunities while enriching the research environment at institutions that award baccalaureates and/or graduate degrees in the biomedical sciences. Eligibility: (I) 25% or more of undergraduate students are supported by Pell grants or (ii) accredited medical/health professional school with a historical mission statement that explicitly states that it was founded to educate students from nationally underrepresented ​ backgrounds. Investigator-Initiated Research Grants (R01) support a discrete, specified, circumscribed project in areas representing the specific interests and competencies of the investigator(s) that fall within the mission of NIGMS.

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For more information about biomedical technology program support for investigator-initiated research grants, contact: Dr. Dorothy Beckett ​Director Division of Biophysics, Biomedical Technology, and Computational Biosciences National Institute of General Medical Sciences National Institutes of Health 45 Center Drive MSC 6200 Bethesda, MD 20892-6200
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What is Investigator-Initiated Translational Research Award?

The FY22 LCRP Investigator-Initiated Translational Research Award mechanism supports translational research that will develop promising ideas in lung cancer into clinical applications. Translational research may be defined as an integration of basic science and clinical observations.
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What are the different types of investigation studies?

Science, as defined by the National Academy of Sciences, is “the use of evidence to construct testable explanations and predictions of natural phenomena, as well as the knowledge generated through this process.” So what does that definition mean? If you look up the definition in an online dictionary, you will see something similar to the following: Notice that the definition has two parts. The first part, “systematic knowledge of the physical or material world,” is a noun. These are the facts that you learn in science class such as the formula for photosynthesis or the different types of chemical reactions.

  • However, science is more than facts.
  • The second part of the definition, “gained through observation and experimentation,” indicates that science is also a verb.
  • Science is a process.
  • It is a way of observing, a way of thinking, and a way of knowing about the world.
  • The goal of science is to provide explanations for events that happen in nature.

Scientists use those explanations to understand patterns in nature and make predictions about future events. Look at the following three investigations. How are they alike? How are they different?

Investigation 1 Investigation 2 Investigation 3
A student used a microscope to observe an amoeba to determine how the organism moved. A student used a hand lens to examine the color and texture of four different rocks. A student planted rye grass seeds in potting soil in three plastic cups, placing them on a window sill, and watering one daily, one every third day, and one not at all.

Scientists use three types of investigations to research and develop explanations for events in the nature: descriptive investigation, comparative investigation, and experimental investigation, Cite Source Sources of images used for this section as they appear, top to bottom: Amoeba proteus, Tashiror, MicrobeWiki Metamorphic rock samples, Glaitness Class, Blogspot Plant experiment, Dennis Anderson, Oklahoma City Community College
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What is the function of the investigative study?

The purpose of the investigation is to explore in detail the allegations, to examine the evidence in depth, and to determine specifically whether misconduct has been committed, by whom, and to what extent. The investigation will also determine whether there are additional instances of possible misconduct that would justify broadening the scope beyond the initial allegations.
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What is a non interventional study?

Definition – An NIS is a study designed to gather insights into the use of authorised or registered medicinal products. These studies are a sub-group of non-interventional trials within the meaning of section 4 paragraph 23 sentence 3 of the Medicinal Products Act (Arzneimittelgesetz, AMG ).

Non-interventional trials are defined as studies, in the context of which findings resulting from individuals’ treatment with medicinal products are analysed using epidemiological methods; the treatment, including the diagnosis and monitoring, does not follow a predetermined trial protocol but results exclusively from current medical practice.

If a medicinal product is used that requires marketing authorisation or approval pursuant to section 21a (1) of the Medicinal Products Act ( AMG ), the treatment shall be carried out according to the specifications regarding its use contained in the marketing authorisation or approval.

  1. NIS are not subject to approval.
  2. Pursuant to section 67 (6) of the AMG, however, the party conducting the study is subject to notification and communication obligations vis-à-vis the competent higher federal authority.
  3. Pursuant to section 67 (6) sentence 10 of the AMG, the competent higher federal authority shall make any notifications and final reports received available to the public on the internet.

: Non-Interventional Studies
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What is the role of a sponsor investigator?

C. Sponsor recordkeeping – The SI is responsible for maintaining the following records.

Drug accountability

Accurate records documenting the receipt, shipment, or other disposition of the investigational drug. These records are required to include, as appropriate, the name of the investigator to whom the drug is shipped, and the date, quantity, and batch or code mark of each such shipment.

Financial interest

Documentation of any financial interests of any of the participating investigators involved in the study (see also 21 CFR 54 ). The sponsor-investigator is responsible for ensuring all participating investigators provide the SI with sufficient accurate financial information to allow the SI to submit complete and accurate certification or disclosure statements.
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What is an investigator meeting in clinical research?

An Investigator Meeting is usually a sponsor’s job, but a CRO may also be delegated with this task. For many from the industry, investigator meeting is much targeted and criticized for overspending. It is argued that these meetings are generally hosted to lure investigators in clinical trials but if we try to understand the need of such events they are much more fruitful than being thought of.

What is an investigator meeting? It is nothing but a group meeting conducted on behalf of sponsor/CROs to train investigators and their lead clinical trial staff on trial related activities, standard operating procedures and to discuss the applicable regulatory picture. The content of an investigator meeting is usually trial specific, nevertheless a common agenda, on SOP’s, Adverse Event Reporting, Source Documentation etc are also discussed.

The meeting has multiple sessions on each aspect of the clinical trial, wherein the pros and cons of trial related activities are discussed. The discussion is also extended towards highlighting the expected issues that investigators may face and how to deal with them.

An investigator meeting ensures to: • Ensure that all investigators have an understanding of how to conduct the trial in strict compliance with the protocol, SOP’s, guidelines and applicable regulations. • To introduce the investigators with Case Report Forms (CRFs). • Document the responsibilities of all participating investigators and its staff and train them prior to the start of the trial.

• Discuss the study protocol in detail. • Facilitate communication between investigators. The ICH guideline for GCP states that investigators “should ensure the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor in the CRFs” (4.9.1).
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What is an investigator in statistics?

Meaning of Investigator and Enumerator. An investigator is a person, who in research exploration, plans and conducts by means of statistical techniques and methods to draw the related inference from a certain research problem. An investigator does all the necessary planning and conducts the necessary research interviews individually or with the help of other individuals of the team.
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What is the best degree for investigator?

What degree should I get if I want to be a private investigator? The field of private investigation is more complex than ever, thanks to people living much of their lives online. Private investigators are known for going undercover and finding answers on everything from fraud to infidelity.

  • Private investigators can be hired by large companies or individuals, depending on their skills.
  • The best degrees for a private investigator are traditionally rooted in law.
  • This could include a or pre-law.
  • For those wanting to focus on the financial sector – including financial fraud – having a bachelor’s in accounting would be an excellent choice.

If you’re wanting to focus on technology, earning a certified forensic analyst designation or certificate is the way to go. This type of degree focuses on recovering information from computer hard drives, email servers, smartphones, tablets, and other pieces of technology.

This type of private investigator typically works in tandem with local law enforcement, the military, and other government agencies as well as IT companies. Other people may wish to specialize in missing persons investigations. This type of private investigator would need an associate’s of science or bachelor’s of science in criminal justice,

Obtaining a bachelor’s of science in criminal justice administration with a specialty in human services would also be a good choice. All of these degrees focus on clear communication skills and being able to access details. This specialization would require a license in addition to the student’s degree of choice, so keep that in mind as you decide what type of private investigation career you’d like to pursue.
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