LIVE ONLINE E-LARNING COURSE
Advanced Program in Clinical Research
Feels Like Real Classroom
APCRM is an Advanced credential that validates expertise in the design, conduct, and management of Clinical Trials. It covers regulatory guidelines, ethical considerations, and data management. This certification enhances career prospects in clinical research organizations, pharmaceuticals, and healthcare. It is typically achieved through accredited programs and passing a certification exam.
![](https://www.cliniversity.com/wp-content/uploads/2024/06/check-icon.png)
Schedule: 5 Days a Week (Monday to Friday)
![](https://www.cliniversity.com/wp-content/uploads/2024/06/check-icon.png)
4 Months Duration
Program Insight
![](https://www.cliniversity.com/wp-content/uploads/2024/06/pepcrpv-pg-slid-img-1.webp)
Clinical Trial Management
![](https://www.cliniversity.com/wp-content/uploads/2024/06/pepcrpv-pg-slid-img-2.webp)
Clinical Data Management
The Clinical Data Management Certification Program focuses on training professionals in the efficient collection, processing, and analysis of clinical trial data. The curriculum covers data standards, database design, data cleaning, quality control, and regulatory compliance. Participants gain proficiency in using specialized software and tools to ensure accurate and reliable data. Successful graduates are well-equipped for roles such as Clinical Data Manager, Data Analyst, or Clinical Research Coordinator. The program enhances career opportunities by providing the skills needed to manage clinical data effectively, ensuring high-quality data for regulatory submissions and supporting the advancement of medical research and development.
![](https://www.cliniversity.com/wp-content/uploads/2024/06/pepcrpv-pg-slid-img-3.webp)
Pharmacovigilance
The Pharmacovigilance Certification Program provides comprehensive training in monitoring and assessing the safety of pharmaceutical products. The program covers adverse event reporting, risk management, regulatory requirements, signal detection, and post-market surveillance. Participants learn to identify, evaluate, and mitigate drug safety risks, ensuring patient safety and compliance with global regulations. Successful completion of the program prepares graduates for roles such as Pharmacovigilance Specialist, Drug Safety Associate, or Risk Management Analyst. Graduates are equipped with the knowledge and skills to manage drug safety data, contribute to regulatory submissions, and enhance the overall safety profile of pharmaceutical products in the market.
![Clinical Research course eligibility](https://www.cliniversity.com/wp-content/uploads/2024/07/Clinical-Research-course-eligibility.png)
Eligibility
B.Pharm, M.Pharm and Pharm.D
B.Sc. M.Sc and Ph.D (Biotechnology, Microbiology, Biochemistry and Nursing etc)
B.E., B.Tech. M.Tech (Biotech/ Biomedical Engineering)
BPT, MPT, BDS, BAMS, BHMS and MBBS etc
Course Syllabus
![](https://www.cliniversity.com/wp-content/uploads/2024/06/pepcrpv-syllabus1.webp)
Clinical trial management
Introduction to Clinical Research
Overview of Clinical Research
History and Evolution of Clinical Research
Types of Clinical Trials
Regulatory Environment and Guidelines
Medical Terminology
Good Clinical Practice (GCP)
International Council for Harmonisation (ICH) Guidelines
U.S. Food and Drug Administration (FDA) Regulations
European Medicines Agency (EMA) Regulations
Ethical Guidelines and Institutional Review Boards (IRBs)
Study Design and Methodology
Clinical Trial Design (Randomized Controlled Trials, Cohort Studies, etc.)
Protocol Development
Sample Size Determination and Statistical Considerations
Randomization and Blinding Techniques
Clinical Trial Management
Roles and Responsibilities in Clinical Trials (Investigators, Sponsors, CROs)
Site Selection and Initiation
Recruitment and Retention of Study Participants
Informed Consent Process
Study Monitoring and Closeout
Safety Reporting and Pharmacovigilance
Adverse Event Reporting
Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs)
Safety Monitoring Committees
Risk Management and Mitigation Strategies
Quality Assurance and Compliance
Audits and Inspections
Quality Assurance Processes
Compliance with GCP and Regulatory Requirements
Handling Non-Compliance and Deviations
Ethical Considerations in Clinical Research
Principles of Bioethics (Autonomy, Beneficence, Non-maleficence, Justice)
Ethical Issues in Clinical Trials (Vulnerable Populations, Consent)
Human Subjects Protection
Confidentiality and Data Privacy
Emerging Trends and Technologies
Digital Health and Mobile Technologies in Clinical Research
Real-World Evidence and Big Data Analytics
Personalized Medicine and Genomics
Innovative Trial Designs (e.g., Adaptive Trials)
Practical Components
Case Studies and Real-World Scenarios
Workshops and Hands-On Training
Mock Clinical Trial Exercises
Software Training (e.g., EDC systems, statistical software)
![](https://www.cliniversity.com/wp-content/uploads/2024/06/pepcrpv-syllabus2.webp)
Clinical Data Management
Introduction to Clinical Data Management
Overview of Clinical Data Management
Role of CDM in Clinical Research
Introduction to Clinical Trials
Life Cycle of Clinical Data
Regulatory Framework and Guidelines
Good Clinical Practice (GCP)
International Council for Harmonisation (ICH) Guidelines (E6, E9)
Regulatory Requirements (FDA, EMA)
Ethical Considerations and Data Privacy (HIPAA, GDPR)
Clinical Trial Design and Methodology
Basics of Clinical Trial Design
Protocol Development
Case Report Form (CRF) Design
Study Endpoints and Outcomes
Data Collection and CRF Design
Types of CRFs (Paper-based, Electronic)
CRF Development and Design Principles
Source Data Verification
CRF Completion Guidelines
Electronic Data Capture (EDC) Systems
Introduction to EDC Systems
EDC System Selection and Implementation
Data Entry and Validation
Advantages and Challenges of EDC
Data Management Plan (DMP)
Components of a DMP
DMP Development and Maintenance
Standard Operating Procedures (SOPs)
Data Flow and Process Mapping
Database Design and Build
Database Design Principles
Database Build and Testing
Data Standards (CDISC, SDTM, ADaM)
Metadata and Data Dictionaries
Data Quality Management
Data Cleaning and Query Management
Data Validation and Edit Checks
Discrepancy Management
Data Quality Assurance and Control
Data Integration and Coding
Data Integration from Multiple Sources
Medical Coding (MedDRA, WHO-DDE)
Laboratory Data Management
Handling Adverse Event Data
Data Analysis and Reporting
Basics of Biostatistics
Data Analysis Plan
Data Listings, Tables, and Figures (TLFs)
Statistical Analysis Software (SAS, R)
Data Lock and Archival
Database Lock Procedures
Data Freeze and Lock Timelines
Archival of Clinical Data
Regulatory Submissions and Inspections
Project and Resource Management in CDM
Project Management Fundamentals
Resource Allocation and Management
Timeline and Budget Management
Communication and Team Coordination
Emerging Trends and Technologies in CDM
Big Data and Real-World Evidence
Artificial Intelligence and Machine Learning in CDM
Blockchain Technology for Data Security
Mobile Health and Remote Data Collection
Discrepancy Management
Introduction to Discrepancies
Identifying Discrepancies
Classification and Prioritization of Discrepancies
Discrepancy Resolution Process
Query Management
Tools and Techniques for Discrepancy Management
Quality Assurance Studies and Practical Exercises
![](https://www.cliniversity.com/wp-content/uploads/2024/06/pepcrpv-syllabus3.webp)
Pharmacovigilance
Introduction to Pharmacovigilance
Definition and Scope
History and Evolution of Pharmacovigilance
Importance and Objectives of Pharmacovigilance
Key Terminologies (Adverse Drug Reaction (ADR), Adverse Event (AE), Signal Detection, etc.)
Regulatory Framework and Guidelines
International Regulatory Bodies (FDA, EMA, MHRA, WHO)
Good Pharmacovigilance Practices (GVP)
ICH Guidelines (E2A, E2B, E2C, E2D, E2E)
Local Regulatory Requirements and Differences
Adverse Event Reporting and Management
Identifying Adverse Events and Reactions
Sources of Safety Data (Clinical Trials, Post-Marketing Surveillance, Literature, etc.)
Spontaneous Reporting Systems
Seriousness, Expectedness, and Causality Assessment
Case Report Form (CRF) and Electronic Reporting (E2B)
Signal Detection and Risk Management
Definition and Importance of Signal Detection
Methods for Signal Detection (Qualitative and Quantitative)
Data Mining Techniques
Signal Management Process
Risk Assessment and Mitigation Strategies (Risk Management Plans, RMPs)
Data Collection and Data Management
Data Sources and Data Flow
Database Management Systems (Safety Databases)
Data Entry and Quality Control
Data Coding (MedDRA, WHO-ART)
Case Processing and Follow-Up
Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs)
Purpose and Content of PSURs and DSURs
Regulatory Requirements and Timelines
Writing and Compiling Reports
Benefit-Risk Evaluation
Submission and Review Process
Risk Communication
Principles of Risk Communication
Communicating Safety Information to Healthcare Professionals and the Public
Labeling Changes and Safety Warnings
Dear Healthcare Professional Letters (DHPLs)
Public Health Advisories
Pharmacovigilance Systems and Processes
Pharmacovigilance System Master File (PSMF)
Standard Operating Procedures (SOPs)
Quality Management System in Pharmacovigilance
Audits and Inspections
Compliance and CAPA (Corrective and Preventive Actions)
Pharmacovigilance in Special Populations
Pharmacovigilance in Pediatrics and Geriatrics
Pregnancy and Lactation Safety Monitoring
Pharmacovigilance for Orphan Drugs and Rare Diseases
Vaccines Safety Monitoring
Pharmacoepidemiology and Pharmacoeconomics
Basics of Pharmacoepidemiology
Study Designs in Pharmacoepidemiology (Cohort, Case-Control, etc.)
Pharmacoeconomic Evaluations
Application of Real-World Evidence in Pharmacovigilance
Emerging Trends and Technologies in Pharmacovigilance
Use of Artificial Intelligence and Machine Learning
Big Data and Real-World Data Utilization
Digital Health and Mobile Technologies
Social Media and Web-Based Pharmacovigilance
thical and Legal Considerations in Pharmacovigilance
Ethical Principles in Pharmacovigilance
Patient Privacy and Data Protection (HIPAA, GDPR)
Legal Aspects and Litigation
Reporting Obligations and Liabilities
Practical Components
Case Studies and Real-World Scenarios
Hands-On Training with Pharmacovigilance Databases (e.g., Argus, ArisG)
Mock Reporting and Documentation
Workshops on PSUR and DSUR Preparation
![](https://www.cliniversity.com/wp-content/uploads/2024/06/pepcrpv-syllabus4.webp)
Soft Skills Training
Our soft skills training program is designed to help fresh students excel in the clinical research field by enhancing their communication, teamwork, and problem-solving abilities. Effective communication is crucial for interacting with patients, colleagues, and regulatory bodies, ensuring clear and accurate information exchange. Teamwork skills foster collaboration within multidisciplinary research teams, leading to more efficient and successful trials. Problem-solving abilities enable students to address and overcome challenges that arise during research projects. Additionally, our training emphasizes time management and organizational skills, essential for handling multiple tasks and maintaining project timelines. With these soft skills, students are better prepared to navigate the complexities of clinical research and build a successful career.
CONTACT US
TO KNOW MORE CALL
Call : +91 7066457703
Or email at info@cliniindia.com
Program Features
Industry expert mentors – Learn from industry experts in our comprehensive program, where seasoned professionals share their knowledge and insights. Gain hands-on experience, practical skills, and up-to-date information on the latest industry trends. Enhance your expertise and advance your career with guidance from leaders in the field.
Outcome Based Training (OBT) : Cliniversity is the only institute who offers outcome based training and placement programs. Experience Outcome Based Training, where the focus is on achieving specific, measurable results. Our program is designed to equip you with practical skills and knowledge that directly impact your professional success. Through targeted learning objectives and real-world applications, you’ll achieve tangible outcomes that enhance your career and personal growth.
24*7 learning through LMS access: A Learning Management System (LMS) streamlines education by providing a centralized platform for course administration, delivery, and tracking. It offers interactive tools, multimedia content, and assessments, enhancing the learning experience. Ideal for both educators and students, an LMS facilitates efficient, flexible, and personalized learning anytime, anywhere.
Regular exercise & assignments : Regular exercise and assignments are integral to our program, reinforcing learning and promoting practical application. Consistent practice through exercises sharpens skills, while assignments ensure comprehension and retention of material. This structured approach boosts confidence, prepares you for real-world challenges, and enhances overall academic performance.
Upgraded training Program : Embark on an upgraded training program designed to elevate your skills and expertise. Featuring the latest industry insights, cutting-edge tools, and advanced methodologies, this program offers an unparalleled learning experience. Stay ahead of the curve and unlock new opportunities for professional growth and success with our upgraded training program.
End to End Placement preparation: Experience comprehensive end-to-end placement preparation, tailored to ensure your readiness for career success. Our program covers every aspect, from resume building and interview techniques to soft skills development. With personalized guidance and extensive resources, we empower you to confidently navigate the job market and secure your ideal placement. Task based mock interviews prepare you perfectly on all aspects.
Easy & Affordable: Easy learning and affordable fees with installments option make this program the 1st choice for the aspirants.
Certification – Clinical Research Certification
Our Medical Coding program offers a valuable certification upon completion, recognizing participants for their dedication to mastering essential coding skills. While not an APPC certificate, our program’s participation certificate signifies your commitment to advancing in the field. Gain practical knowledge, boost your resume, and open doors to exciting opportunities in healthcare coding.
![](https://www.cliniversity.com/wp-content/uploads/2024/05/courses-certificate-image.webp)
OUR PLACEMENTS
Career Triumphs: APCRM Graduates Shine Bright in Corporate Placements
Job Profiles- (Designations and Roles)
![](https://www.cliniversity.com/wp-content/uploads/2024/06/pepcrpv-job-profiles-img-1.webp)
CLINICAL TRIAL MANAGEMENT JOB PROFILES
Clinical Research Coordinator (CRC):
1. Protocol Implementation: Ensure adherence to study protocols and regulatory requirements at the study site.
2. Participant Recruitment: Screen and enroll eligible participants according to study criteria.
3. Informed Consent: Facilitate the informed consent process, ensuring participants understand the study risks and benefits.
4. Data Collection: Collect and record accurate and complete study data, including medical histories and study-specific assessments.
5. Study Documentation: Maintain regulatory documentation, including case report forms (CRFs) and investigator site files (ISFs).
6. Study Coordination: Coordinate study visits, procedures, and follow-up activities for participants.
7. Safety Reporting: Monitor and report adverse events (AEs) and serious adverse events (SAEs) to the appropriate regulatory authorities and study sponsors.
8. Quality Assurance: Ensure compliance with Good Clinical Practice (GCP) guidelines and internal standard operating procedures (SOPs).
9. Communication: Serve as the primary point of contact between the study site, investigators, sponsors, and regulatory authorities.
10. Training and Education: Provide training to study staff and investigators on study protocols, procedures, and regulatory requirements.
Clinical Research Associate (CRA):
1. Site Monitoring: Conduct routine site visits to ensure protocol compliance, data integrity, and participant safety.
2. Site Initiation: Perform site initiation visits (SIVs) to train study staff and ensure readiness for study initiation.
3. Site Closeout: Conduct site closeout visits to ensure all study activities are completed, data is accurate, and regulatory documents are archived appropriately.
4. Data Verification: Review and verify study data against source documents, ensuring accuracy and completeness.
5. Query Resolution: Generate and track data queries to resolve discrepancies or missing information in study data.
6. Regulatory Compliance: Ensure compliance with GCP, regulatory requirements, and study protocols.
7. Study Documentation: Maintain and update trial master files (TMFs) and other study documentation as per regulatory standards.
8. Risk Management: Identify and mitigate risks to study quality, participant safety, and data integrity.
9. Communication: Communicate effectively with study sites, sponsors, and other stakeholders to address study-related issues and ensure timely resolution.
10. Reporting: Prepare monitoring reports, study progress updates, and other documentation for internal and external stakeholders.
Principal Investigator (PI): If you are from a medical background then you can work as a Principal Investigator (PI). PI holds the primary responsibility for the conduct of a clinical trial at the investigative site. Their role is pivotal in ensuring the safety of participants, the integrity of data, and compliance with regulatory requirements.
![](https://www.cliniversity.com/wp-content/uploads/2024/06/pepcrpv-job-profiles-img-2.webp)
CLINICAL DATA MANAGEMENT JOB PROFILES
Clinical Data Manager (CDM):
- Responsible for overseeing the collection, validation, and analysis of clinical trial data.
- Develops data management plans and ensures adherence to protocols and regulatory requirements.
- Manages data cleaning, coding, and database lock processes.
- Coordinates with study teams, vendors, and stakeholders to ensure data quality and timelines.
Clinical Database Programmer:
- Designs, develops, and maintains databases for clinical trial data
- Implements data validation checks and edit checks to ensure data accuracy and completeness.
- Generates data listings, tables, and figures (TLFs) for analysis and reporting.
- Provides technical support for database-related issues and query resolution.
Clinical Data Coordinator:
- Supports data management activities, including data entry, verification, and cleaning.
- Assists in the development of case report forms (CRFs) and data management plans.
- Performs quality control checks on data and resolves discrepancies.
- Communicates with study sites and monitors for timely data submission and query resolution.
Clinical Data Analyst:
- Analyzes and interprets clinical trial data to identify trends, patterns, and outliers.
- Conducts statistical analysis and generates summary reports for study teams.
- Participates in data review meetings and contributes to data interpretation discussions.
- Assists in the preparation of study manuscripts and presentations.
Clinical Quality Assurance Specialist:
- Conducts quality assurance audits to ensure compliance with Good Clinical Practice (GCP) guidelines and regulatory requirements.
- Reviews study documentation, data management processes, and study conduct for adherence to protocols.
- Provides recommendations for process improvements and corrective actions.
- Assists in the preparation for regulatory inspections and audits.
Principal Investigator (PI)
- Protocol Development: The PI may contribute to the development of the study protocol, ensuring it aligns with ethical principles, regulatory guidelines, and scientific validity.
- Study Site Selection: The PI selects and evaluates potential study sites, ensuring they have the necessary infrastructure, resources, and expertise to conduct the trial effectively.
- Participant Recruitment and Informed Consent: The PI oversees participant recruitment efforts, ensuring adherence to eligibility criteria and ethical standards. They are responsible for obtaining informed consent from participants or ensuring delegated staff members do so.
- Study Conduct: The PI is responsible for the overall conduct of the study at the investigative site, including oversight of study procedures, participant care, and data collection.
- Safety Monitoring: The PI monitors participant safety throughout the trial, promptly reporting adverse events (AEs) and serious adverse events (SAEs) to regulatory authorities and the sponsor.
- Data Collection and Management: The PI ensures accurate and complete collection of study data, including adherence to data entry procedures and timely completion of case report forms (CRFs).
- Regulatory Compliance: The PI ensures compliance with Good Clinical Practice (GCP) guidelines, local regulations, and institutional policies throughout the trial.
- Investigational Product Management: If applicable, the PI is responsible for the handling, storage, dispensing, and accountability of investigational products according to protocol requirements.
- Site Monitoring and Audits: The PI may interact with clinical research associates (CRAs) during site monitoring visits and assist with audits and inspections conducted by regulatory authorities or sponsors.
- Study Closeout: The PI ensures that all study-related activities are completed according to the protocol and regulatory requirements, facilitating the timely submission of study documents for closeout.
![](https://www.cliniversity.com/wp-content/uploads/2024/06/pepcrpv-job-profiles-img-3.webp)
PHARMACOVIGILANCE JOB PROFILES:
Pharmacovigilance Specialist:
- Collects, evaluates, and reports adverse drug reactions (ADRs) and adverse events (AEs) from healthcare professionals, patients, and literature sources.
- Conducts case processing activities, including data entry, coding, and narrative writing.
- Performs medical review of individual case safety reports (ICSRs) to assess causality and seriousness.
Drug Safety Associate:
- Assists in the collection, processing, and reporting of adverse events and safety data.
- Conducts initial triage and assessment of ICSRs for completeness and accuracy.
- Supports medical review activities and assists in signal detection and risk management tasks.
Pharmacovigilance Manager:
- Oversees pharmacovigilance operations and staff, ensuring compliance with regulatory requirements and company policies.
- Manages the processing, assessment, and reporting of adverse events in accordance with global pharmacovigilance regulations.
- Provides leadership and guidance on pharmacovigilance processes, risk management, and safety surveillance activities.
Pharmacovigilance Physician:
- Provides medical expertise in the evaluation and assessment of adverse events and safety signals.
- Conducts medical review of individual case safety reports (ICSRs) to determine causality, seriousness, and expectedness..
- Supports risk management activities, including safety assessments, signal detection, and risk minimization strategies.
Pharmacovigilance Scientist:
- Conducts signal detection and data analysis activities to identify potential safety concerns and emerging risks.
- Performs literature review and analysis to gather safety-related information and evidence.
- Collaborates with cross-functional teams to assess and mitigate safety risks throughout the product lifecycle.
Regulatory Affairs Specialist:
- Ensures compliance with pharmacovigilance regulations and guidelines, including reporting requirements and submissions to regulatory authorities.
- Supports the preparation and submission of periodic safety reports (PSURs), risk management plans (RMPs), and other regulatory documents.
- Provides regulatory guidance on pharmacovigilance-related issues and assists in regulatory inspections and audits.
Quality Assurance Specialist:
- Conducts audits and inspections to evaluate compliance with pharmacovigilance regulations, standard operating procedures (SOPs), and quality standards.
- Reviews pharmacovigilance processes, procedures, and documentation for adherence to regulatory requirements.
- Provides recommendations for process improvements and corrective actions to ensure data integrity and patient safety.
MEET OUR Alumni
What’s Students Say about Cliniversity
Hands-On Training in Pharmacovigilance
Database
Case Studies and Practical Approach
Practical training in medical coding is Important as it bridges the gap between theory and real-world application. Case study bases learning equips aspiring coders with hands-on experience crucial for accuracy and efficiency. It enhances proficiency in code assignment, ensures compliance with evolving guidelines, and fosters a deep understanding of the intricacies within the healthcare landscape. Practical training cultivates problem-solving skills, critical thinking, and adaptability, preparing coders for the dynamic challenges they’ll face in the industry. This experiential learning not only solidifies theoretical knowledge but also instills confidence, making individuals better-prepared and more effective contributors to the essential field of medical coding.
![Certificate](https://www.cliniversity.com/wp-content/uploads/2024/07/Certificate.png)
Here Is The Most Frequently Asked Questions
Whats a Hands On database training means
Hands on database training means where participants engage directly with database systems. Each candidate receives separate login credentials to practice in the database. Through practical exercises, real-world scenarios, and guided instruction, learn database design, querying, and management techniques.
What will be the right profile for me to start a career?
It totally depends on your area of interest. However, all these domains and the good career opportunities and career prospects. We believe that you will automatically understand your area of interest when you start learning.
Are you providing 100% placements?
Yes, the program is designed to equip you with the right knowledge and skills to make your professional ready and get you 100 % placements. But, we never guarantee 100% placement as it totally depends on requirements from the industry, how you developed during the certification program and how you perform at the time of interview.
Can I pay the fees in installments?
Yes. To know the installment options call on +91-7066457703
How long will you provide placement assistance?
You will get lifetime placement assistance.
What if I miss any session?
Don’t worry, We are giving you Learning Management System (LMS) access which will be with your 24*7. It streamlines education by providing a centralized platform for course administration, delivery, and tracking. It offers interactive tools, multimedia content, and assessments, enhancing the learning experience. Ideal for both educators and students, an LMS facilitates efficient, flexible, and personalized learning anytime, anywhere.
Is there any waive off in fees?
You can check if there is any waive off in fees. Call +91-7066457703
In which companies do you provide the placements?
There are multiple industries where you can get placement assistance.
- IT healthcare – Accenture, TCS, Cognizant, TCMS, Wipro
- Contract Research Organizations (CRO) – Fortrea, IQVIA, Parexel, Syneos, PPD, Covance, ICON, JSS, JVK, Lambda, SIRO clinpharm,
- Medical Coding Companies : Optum, Episource, Agilon Health, GEBBS, IKS, Advantmed, Augmedix, CorroHealth
- Pharmaceutical companies – GSK, Astrazenica, Novo Novartis, Pfizer, Abbott and more
- Multispeciality Hospitals
- Medical Writing & Scientific writing companies : Cactus communication, Springer, Elsevier, Crest Premedia