Who this is for
- Science, pharmacy, biotechnology, and life-sciences graduates
- Candidates exploring clinical trial operations roles
- Learners who need practical exposure to trial documents and safety workflows
Clinical trials foundation
Online Clinical Research Course
Learn the clinical trial process, GCP, protocol essentials, safety reporting, monitoring basics, and documentation as a foundation before CDM, PV, CRA, or clinical data careers.
Outcomes
- Understand clinical trial phases, designs, and core regulations
- Read protocols, informed consent forms, CRFs, and essential documents
- Explain sponsor, investigator, CRA, CRC, CRO, IRB, and IEC responsibilities
- Understand safety reporting, monitoring, SDV, coding, and reconciliation basics
Tools and topics
Core concepts and platforms covered through examples, assignments, and interview preparation.
ICH GCPCRFMedDRAWHO Drug
Course content
Structured modules for practical learning.
1
Clinical Research Basics
- Introduction to clinical research
- Types, designs, and phases of clinical trials
- INDA, NDA, and ANDA applications
- Contract Research Organizations
2
Regulations and Responsibilities
- ICH GCP guidelines including ICH E6
- Roles and responsibilities of investigator and CRA
- Roles and responsibilities of sponsor and CRC
- Institutional Review Boards and Ethics Committees
3
Documents and Safety
- Protocol contents with examples
- Informed Consent Form
- Investigator's Brochure
- Essential documents
- Participant safety and adverse event reporting
4
Monitoring and Data
- Monitoring at participating sites
- Source Data Verification
- CRF design guidelines
- Data coding using MedDRA and WHO Drug
- SAE and AE reconciliation
Potential recruiters
Training connected to pharma, CRO, healthcare data, and technology roles.
FAQs
Clinical Research questions
Quick answers for candidates evaluating this course before applying.
Who is the Clinical Research course best for? +
Science, pharmacy, biotechnology, and life-sciences graduates Candidates exploring clinical trial operations roles Learners who need practical exposure to trial documents and safety workflows
What will I learn in Clinical Research? +
Understand clinical trial phases, designs, and core regulations Read protocols, informed consent forms, CRFs, and essential documents Explain sponsor, investigator, CRA, CRC, CRO, IRB, and IEC responsibilities Understand safety reporting, monitoring, SDV, coding, and reconciliation basics
Is this course instructor-led? +
Yes. Clini Data Curve courses are positioned as instructor-led live online training with recordings, assignments, assessments, resume preparation, mock interviews, and placement assistance.
How do I apply for this course? +
Use the Apply Now button or enquiry form to share your details and selected course. The team can guide you on batches, fit, and next steps.