Best Clinical Data Management Training Hyderabad

 Being one of the best institutes for training, IGCP has designed an excellent Clinical Research Institute in Hyderabad, which includes various documents used in clinical trials such as protocols, new drug applications, study reports, papers for publication and Includes preparing papers for publication. Regulatory officer etc.

Medical professionals require training in clinical research, as it is not included in the medical curriculum. We are providing training to such candidates to supply qualified professionals for the pharmaceutical industry and enhance quality products. Diagnostic testing is a method of testing new methods of diagnosing, treating, or preventing health conditions. The purpose is to determine if something is both safe and effective.

 

At IGCP, we believe that in today's world of knowledge, it is important to know what, when and how to study. We appoint all the candidates as mentors, who help students overcome the challenges they face in building a rewarding career in Online clinical research courses in Hyderabad.

The purpose behind this course

 the course aims to train students to identify undesirable clinical trials, pharmacodynamics properties of a substance that maybe relevant to human safety.

/ To evaluate adverse pharmacodynamics, clinical research and /or pathophysiological effects of a substance seen in toxicology and/or clinical studies.

Research To investigate the mechanisms of adverse clinical research, pharmacovigilance, pharmacodynamics effects observed or suspected.

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Prerequisite for clinical research course

The curriculum is designed for postgraduates in science, medicine, dentistry, nursing, animal science, pharmaceutical science and biology, biotechnology and bioinformatics etc.

 

Detailed Syllabus of Clinical Research Training Institute in Hyderabad

1. Clinical Research Basic and Drug Development Process

Review the FDA approved process for the development and approval of a drug, the role of the key player in drug development.

2. Informed consent process and human subject protection

Major events in history that have affected human subject rights, reviewed the informed consent process, and described regulatory requirements.

3. GCP Regulation and Guidelines

Key concepts in regulatory application such as GCP, Regulation Guidance and ICH Guide Line. Review FDA's mandatory regulations that sponsor and IRBs.

4. Collection, Review and Submission of Regulatory Documents Review the regulatory documents that must be collected and maintained, discuss the role of these regulatory documents, identify strategies to ensure their precise completeness, review the study files.

5. Introduction to the management of adverse events (AEs) and serious adverse events (SAEs) AEs and SAEs that occur during the conduct of a clinical study, sponsor these events and outline regulatory expectations for the identification, documentation and reporting to the FDA works out. . , The review process and systems involved in safety management and pharmacovigilance in both domestic and global trials.

6. Protocol and Data Management

Review the purpose of protocols and key factors from both CRA and site potential, and their role in handling protocol departures, types of data collection and regulatory requirement and industry standards to retrieve and analyze subject data.

7. Site Interaction

Review communication skills and concepts for interaction with site personnel; Indicate the key principles for establishing a productive work relationship and strategies to deal with site problems.

8. Managing clinical supplies / laboratories

Review CRA's role and regulatory responsibilities for managing accountability of clinical supply laboratories and test articles during trial operations. Address testing, non-compliance and policy issues to prevent or address non-pause.

9. FDA inspects

Review the purpose of FDA inspection, preparation for FDA inspection, activity during an inspection, and the outcome of an inspection activity after FDA inspection

10. Source Document Verification

A brief review of basic data management concepts, source documentation discusses the actual process of validation, addresses CRA responsibilities, strategies, and helpful hints for attacking data and problem resolution.

11. Training Orientation

Monitoring Trainee's review role, including site objectives, pre-approval requirements for site visits, site visit planning, on-site visit and expense forms, site visits and documentation, and training for independent site visits Signature for

12. Interim trip

Review the activities occurring during the interim site visit and discuss the methodology to solve the most common problem that occurs at investigative sites.

13. Turn off site audit and inspection

Familiarize the new CRA with the activities that take place at the end of a test and their responsibilities to complete these activities.