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Clinical Research Trainings


What is clinical research

Clinical research is a branch of healthcare science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical Research is different than clinical practice. In clinical practice one uses established treatments, while in clinical research evidence is collected to establish a treatment.

Once the promising molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the test article (including its safety toxicity if applicable and efficacy, if possible at this early stage) are studied.Thereafter Clinical research includes clinical trials, which are studies on human beings that evaluate the effectiveness and safety of medical devices or drugs for consumption in mankind.

What are Clinical Trials

Clinical trials are prospective biomedical or behavioral research studies on human subjects that are designed to answer specific questions about biomedical or behavioral interventions (novel vaccines, drugs, treatments, devices or new ways of using known interventions), generating safety and efficacy data.[1] They are conducted only after satisfactory information has been gathered that satisfies health authority/ethics committee approval in the country where approval of the therapy is sought.

Depending on product type and development stage, investigators initially enroll volunteers and/or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. As positive safety and efficacy data are gathered, the number of patients typically increases. Clinical trials can vary in size, and can involve a single research entity in one country or multiple entities in multiple countries.Thus these trials are conducted in fourphases , each being more complex than the earlier one. On successful completion of the studies, the data collected are submitted to the regulatory authorities for seeing permission to market the drug.

In brief clinical trials are an essential part of the drug development programme, following animal studies and prove that the drug has the safety and efficacy to be used in humans.

PHASES OF CLINICAL TRIALS

  • Phase I : : Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
  • Phase II : The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
  • Phase III : The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
  • Phase IV : Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Operations

  • Introduction to Clinical Research and clinical trial
  • Clinical Research and India and opportunities
  • Drug Development and Pre clinical studies
  • Principles of ICH GCP guidelines
  • History and Phases of clinical trials
  • Institutional Review Board
  • EC submissions and correspondences
  • Informed Consent -- Elements and Documentation
  • Case Report Form
  • Essential documents in clinical research
  • Clinical Trial design
  • Protocol as a Clinical tool
  • Investigator brochure
  • Feasibility of a site
  • Trial Monitoring and conduct of a trial
  • CRA responsibilities
  • Subject recruitment and retention
  • Essential documentsv
  • CRFs( including electronic CRF),Archival procedures,
  • Site study budget
  • SAE/AE reporting and safety reporting
  • Site Audits
  • Quality Assurance and Documentation
  • Misconduct and Fraud
  • Flow of events-Site
  • Investigator responsibilities
  • Sponsor responsibilities
  • Insurance and Indemnity
  • Pharmacovigilance
  • Medical Writing
  • Project management
  • Biostatistics

Regulatory Aspects of Clinical Research

  • History behind regulations
  • Evolution of ICH GCP
  • Principles of ICH GCP
  • Nuremberg code
  • Declaration of Helsinki
  • Belmont report
  • Tuskegee Syphilis Study
  • Schedule Y
  • Drugs and cosmetics act
  • FDA
  • ICMR guidelines
  • PSUR
  • EMEA

Data management

  • Data management plan
  • Data capture
  • Data collection
  • Data entry
  • Trial review and validation
  • Database design
  • Data Discrepancy checks
  • Discrepancy management
  • Coding
  • Generating query
  • Data followup
  • Data privacy
  • Lab data and Range checks
  • Paper CRF and EDC based study
  • CRF design and log in and inventory
  • Medra
  • Data storage and archival
  • Data management work flow
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