General

About Clinical Research

• Introduction to clinical research File
• Clinical research past, present and future File
• Clinical research India and Worldwide File
• Development of GCP ICH and India File
• Stake holders in clinical research File
• Quiz for About Clinical Research

  Restricted Not available unless:

  • The activity Introduction to clinical research is marked complete
  • The activity Clinical research past, present and future is marked complete
  • The activity Clinical research India and Worldwide is marked complete
  • The activity Development of GCP ICH and India is marked complete
  • The activity Stake holders in clinical research is marked complete

Clinical pharmacology and drug development

• Drug development and discovery File
• Properties of drugs, Drug dosage forms, Formulation development and Manufacture of drugs File
• Pharmacodynamics, Mechanisms of drug action File
• Pharmacokinetics File
• Taxicology File
• Drug adverse reactions File
• Quiz for Clinical pharmacology and drug development

  Restricted Not available unless:

  • The activity Drug development and discovery is marked complete
  • The activity Properties of drugs, Drug dosage forms, Formulation development and Manufacture of drugs is marked complete
  • The activity Pharmacodynamics, Mechanisms of drug action is marked complete
  • The activity Pharmacokinetics is marked complete
  • The activity Taxicology is marked complete
  • The activity Drug adverse reactions is marked complete
  • The activity Quiz for About Clinical Research is complete and passed

Clinical Trials

• Introduction to clinical trials File
• Ethics in clinical research File
• Phase 0 to IV clinical trials File
• Clinical trial designs File
• Bioequivalence studies File
• Pharmacological studies File
• Clinical trials of special products File
• Conduct of clinical trials File

Therapeutic areas

• Therapeutic areas -part 2 oncology File
• Therapeutic areas -part 2 CNS File
• Therapeutic areas & diseases File
• Therapeutic areas -part 1 infectious diseases File
• Therapeutic areas -part 1 inflammation & immunology File
• Therapeutic areas -part 1 haematology File
• Therapeutic areas -part 1 gastroenterology File
• Therapeutic areas -part 3 respiratory File
• Therapeutic areas -part 3 cardiovascular and metabolic File
• Therapeutic areas -part 3 endocrinology File
• Therapeutic areas &diseases anatomy and physiology of human body File
• Therapeutic areas -part 1 ear, nose and throat disorder File

Clinical Trial Regulations

• Clinical trial regulations India and Internationals File
• Global clinical trial regulations File
• Clinical trial regulations India and Internationals File
• Common technical documents, IND and NDA requirements File
• Clinical trial regulations in India DCG(I) structure and functions File
• The drugs and cosmetics act and rules File
• Online clinical trial application and monitoring system File
• Guidance for import and/or manufacture of new drug for clinical trials or marketing in India File

Clinical Trial Initiation and Site Start Up

• Site and investigator selection File
• Investigator's meeting File
• Initiation visit File
• IP Handling File
• AE Reporting File
• Site personnel investigator, CRA & CRC responsiblities File
• Monitoring of trials File
• Site management organizations File
• Clinical trial documentation File
• Storage & archival of documents and data File

Clinical quality assurance and control

• Clinical quality assurance and control File
• NABH accriditation of ECs File
• GCP/GMP/GLP File
• SOP writing for clinical research File
• Audits and Inspections File
• Compliance & non-compliance File
• Fraud and misconduct File

Project Management

• Project management in clinical research File
• Investigator initiator trials File
• Budgeting of clinical trials File
• Insurance, compensation and indemnification of trial subjects File
• Clinical trial outsourcing File
• Review of FDA form 1572 and financial disclosure File
• PM tools and techniques applied in clinical research File

Pharmacovigilance

• Introduction to pharmacovigilance File
• PV in clinical trials File
• Case handling process File
• PMS and PSUR File
• Signal detection and risk management File
• Indian pharmacovigilance and safety standards : regulations &guidelines File
• PV ICH E2E guidelines File
• PV EU regulations File

Clinical Data Management

• Overview of clinical data management File
• Data management plan File
• Electronic data capture File
• Data capture methods File
• Case report form File
• Designs of case report form File
• Data entry methods File
• Clinical Coding File
• Discrepancy management File
• Data cleaning File
• Database closure and freezing File
• Clinical data management File
• System in clinical trial File

Roles and Responsibilities

• Roles and Responsibilities File
• Basics of good medical writings File
• Overview of the regulatory, marketing and drug promotion processes common technical document writing File
• Types of writing in clinical research File
• Regulatory writing File
• Publication writing File
• Disclosure writing File
• Medico marketing File
• Review process (peer, technical and data) File

Statistics

• Introduction to statistics File
• Measures of central tendency, variance File
• Significance of mean - clinical application File
• Statistics - parametric and nonparametric tests File
• Statistics - choice of tests File
• Statistics - role of a statistician, programming File

Clinical Research Market

• Clinical research market : global & India File
• Role of CROs and KPOs/BPOs File
• Clinical Trial outsourcing and agreements File
• Scope of business development File
• Career opportunities in clinical research File

Relationship Management

• Interpersonal relationship skills File
• Corporate etiquettes & workplace behavior File
• Stress management File
• Group Dynamics & team building File
• Conflict management File
• Performance appraisals File
• Time management File
• Soft skill development File
• Interviews skills and etiquettes File
• Writing compelling CV and covering letter File