SG Pharma Trainings

Course available for 1 year after purchase

Trainers: 
1) Neelima mam For Clinical Research

2) Navshin mam For Clinical Data Management


- Introduction to Clinical Research

- History of Clinical Research

- Evolution of GCP

- ICH, Contents & it's Importance.

- Glossary terms 1

- Glossary terms 2

- Glossary terms 3 & GCP principles

- Stake Holders in Clinical Research

- Roles & Responsibilities of PI

- Roles & Responsibilities of Sponsor

- Roles and Responsibilities of EC

- Roles & Responsibilities of CRA, CRC

- Role of Subject in Clinical Trials & Inform Consent process

- Role of RA, Biostatistician & Clinical Data Manger in trials

- Monitoring in Clinical Trials

- Clinical Trial Design

- Essential Documents in Clinical Trials

- Investigator's Brochure & Protocol

- Clinical Trial overview

- Doubts & Query Resolving
Session

In Addition to the Given syllabus students will also get to know about the different aspects of Clinical trial practices

Clinical Data Management:

- Introduction & Glossary

- Guidelines for CDM

- CDM Process & Review/Finalization of study documents

- Database designing & Development /design of CRF

- Data collection & CRF tracking, CRF Processing & Inventory from site

- Data Entry / Data Validation

- Discrepancy Management & Medical Coding

- Database locking, QA/QC checks & Data storage and Archival

- Tools for CDM & Roles & Responsibility in CDM

- Clinical Trial overview



Important information about Clinical Research:

Clinical research is medical research that studies people to understand health and disease. Clinical research helps improve the way doctors treat and prevent illness. Through clinical research, researchers learn:

How the body works

How illness develops in people, such as how diseases get better or worse over time

How the body handles a possible treatment

Which behaviors help people stay healthy and prevent illness, and which behaviors raise the chance of illness?

The goal is to use science to improve people’s health care and health over time. The participants who join and take part in clinical research studies may or may not get any benefit for themselves.

There are 2 main types of clinical research:

Clinical trials, also called interventional studies.

Observational studies

Both may try to learn more about an intervention, which may be a drug, behavior, or medical device. The main difference is clinical trial participants are assigned to get an intervention, but observational study participants are not assigned to get an intervention.

Clinical trials

Clinical trials are research studies in which researchers assign participants to get one or more interventions to test what happens in people. Because of this, clinical trials are also called interventional studies. Often, the intervention is investigational, which means it is not approved for doctors to prescribe to people.

In some clinical trials, researchers assign participants to interventions randomly. This means that researchers assign the participants by chance. Usually, participants (or their doctors) don't choose what intervention they will get when they join a clinical trial.

Important note for grand test:

"Please note that only one attempt is allowed for the Grand Test section. It will only be accessible upon completing the course. There will be no additional chances for attempting the test. Thank you for your understanding."

This message communicates the limited opportunity for taking the Grand Test section and emphasizes the importance of completing the course before attempting it.

Certificate course in Clinical Research & Clinical Data management

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Clinical Research & Clinical Data management

Maharashtra

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Hey! I’m learning with SG Pharma Trainings and you can too. Here’s a course you might like: Certificate course in Clinical Research & Clinical Data management by SG Pharma Trainings
    https://www.sgpharmatrainings.com/courses/390792?utm_source=telegram&utm_medium=social&utm_campaign=web-course-share

Hey! I’m learning with SG Pharma Trainings and you can too. Here’s a course you might like: Certificate course in Clinical Research & Clinical Data management by SG Pharma Trainings
    https://www.sgpharmatrainings.com/courses/390792?utm_source=linkedin&utm_medium=social-link&utm_campaign=web-course-share

Hey! I’m learning with SG Pharma Trainings and you can too. Here’s a course you might like: Certificate course in Clinical Research & Clinical Data management by SG Pharma Trainings
    https://www.sgpharmatrainings.com/courses/390792?utm_source=copy-link&utm_medium=social&utm_campaign=web-course-share

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