Clinical Research Management Online Course Fall / Winter 2016
Tuesday, November 1, 2016 - Thursday, February 9, 2017
The New York Academy of Sciences
Clinical Research Management is a rapidly growing industry and requires trained professionals in the cross functional domain of Bio-IT. With the increasing demand for medicines, there is a building pressure of pharmaceutical research and development and using computational tools is automating many of these processes and making them more efficient. Clinical research is one such growing industry area that requires trained specialists in Bio-IT.
The Certificate in Clinical Research Management is designed to provide extensive training in the niche domain of clinical research and clinical data management. It incorporates end-to-end training on all clinical research areas with a special focus on clinical data management processes, documentation, and clinical data management systems. The course includes extensive practical sessions to provide rigorous hands-on experience on a Clinical Data Management System (CDMS) which is widely used in the pharmaceutical industry today. It provides hands-on experience in Protocol Development, Case Report Form development, Clinical Database Planning, Designing, Clinical Data Entry, Definition, Discrepancy Management, and Writing Validation Procedures.
Course Structure and Details
The course is divided into two parts:
- Part 1: Clinical Research (Weeks 1–6)
- Part 2: Clinical Data Management / Oracle Clinical (Weeks 7–13)
Case studies:
- The case study for Oracle Clinical should be completed by end of the respective sessions. All directions will be provided by the faculty during the Q&A session.
Final exam:
- Final exam will consist of Clinical Research and Clinical Data Management modules only. Oracle Clinical is not included in the final assessment.
- Certificate of Completion and Reference Letter
Requirements:
Participants must satisfactorily complete all course assignments and tests in order to be eligible for a certificate of completion.
Registration Pricing
| Member | $1350 |
| Member (Student / Postdoc) | $1200 |
| Nonmember | $1500 |
| Nonmember (Student / Postdoc) | $1400 |
Course Objectives
1. Training the students on complete Clinical Research Processes including:
- Good Clinical Practices,
- Roles and responsibilities of a clinical research associate,
- Understanding IRBs and Informed Consent Processes,
- Case Report Form,
- Regulatory Compliance,
- Drug Inventory Management,
- Sponsor/FDA Audit Preparedness,
- Drug Returns and Records Return Functions, and
- Site Closeout Responsibilities.
2. Practical training in the process of Clinical Data Management.
3. Develop advanced understanding about the Clinical Data Management Process, Systems, Techniques, and Documentation.
4. Provide hands-on training on a Clinical Data Management System using Oracle Clinical from Study Setup to Database Lock using sample study documentation.
5. Interactive exercises and case studies.
6. Projects
Minimum IT Requirements For Oracle Clinical Training Program
Operating system supported:
- Microsoft Windows XP; Service Pack 1, 2, or 3; 32-bit architecture (US English)
- Microsoft Windows Vista; Service Pack 1; 32-bit architecture (US English)
- Microsoft Windows 7; Service Pack 1; 32-bit or 64-bit architecture (US English)
Please note that Mac Operating System is not supported.
Supported browsers:
Only Microsoft Internet Explorer versions are supported and depend on the operating system:
- Microsoft Windows XP: Internet Explorer 8
- Microsoft Windows Vista: Internet Explorer 8
- Microsoft Windows 7: Internet Explorer 8 or 9
- Microsoft Windows 8: Internet Explorer 10
Please note that Safari/Chrome or other browsers are not supported.
Course Policy
Extenuating circumstances:
1. If you have extenuating circumstances that prevent you from assignments, Mid Term quiz, Final exam, or participating in the class, please contact the Instructor or Teaching Assistant to make alternative arrangements.
2. Active communication is the key to overcoming any hurdles you may encounter during the term.
Ways to Contact Instructors
There are two ways to get in touch with the instructor:
1. Forums: Questions can be addressed via Forums.
2. Q/A Sessions: The question and answer sessions will be held on Thursdays at 7:30 pm – 8:30 pm (EST). Questions related to the course work, assignments, case study can be addressed.
Late Work Policy
No assignments will be accepted after the deadlines mentioned by the faculty. If there are extenuating circumstances, then the course instructor's permission has to be explicitly requested ahead of time.
Course Agenda
- Students are responsible to complete all the readings and homework every as self-study (self pace) sessions.
- All Question & Answer (Q&A) sessions will be live WebEx Faculty led Online sessions on Thursdays, 7:30 pm – 8:30 pm EST
Part 1: Clinical Research
Week One: November 1, 2016
CR1 Module 1: Introduction to Clinical Trial Area, Good Clinical Practice trials, Evolution, and Regulations — Topics and Learning Outcomes
- Introduction to Clinical Trial Area
- Explore the need for clinical trials
- Discuss the objectives of phases of clinical trials
- Elaborate all phases of clinical trials, including their importance, need, and significance
- Understand the outcome of all phases
- Understand the outcome of these phases
- Understand the recently introduced new phases of clinical trial
- Good Clinical Practice Trials
- Understand the Good Clinical Practice (GCP) guidelines
- Discuss the history behind GCP
- Discuss the various principles of GCP and how these guidelines are met in clinical trials
- List the key players responsible for GCP implementation
- Evolution and Regulations
Week Two: November 8, 2016
CR1 Module 2: Roles and Responsibilities of Sponsor, PI, and Regulators Clinical Research Coordinator Roles and Responsibilities and Functions in Federally Funded and Pharmaceutical Sponsored Trials
- Roles and Responsibilities of Sponsor, PI and Regulators
- Discuss the roles and responsibilities of various stake holders in clinical research
- Elaborate on the role of a Sponsor in clinical trial
- Detail the responsibilities of a Clinical Research Associate
- Discuss the role of the Principal Investigator
- Clinical Research Coordinator Roles and Responsibilities and Functions in Federally funded and Pharmaceutical Sponsored Trials
Week Three: November 15, 2016
CR1 Module 3: Preparation of Trial Site and Personnel for Protocol, Understand IRB and Informed Consent Process
- Preparation of Trial Site and Personnel for Protocol
- HIPAA
- Understand the HIPAA law
- Discuss the "Protected Health Information" and its implications
- List the effects of HIPAA on research activities
- Detail the process of obtaining the protected health information
- Describe Authorization and detail the Waiver of Authorization
- Understand IRB and Informed Consent Process
- Discuss the history and detail the importance of Informed Consent in Clinical Research
- Detail Informed Consent guidelines
- Elaborate on the basic and additional elements of Informed Consent
- Describe the Informed Consent process
- Discuss the documentation of Informed Consent
- Understand the Institutional Review Board and the regulations behind it
- Discuss the history of unethical trials and the origin of the Belmont principles
- Elaborate on the composition of IRB and it's membership list
- Distinguish between the IRB and the IEC
- Detail the IRB review process
- Discuss the continue review process of an IRB
- Elaborate on the Investigator's responsibility towards the IRB
- Discuss the timelines for keeping IRB/IEC records
Week Four: November 22, 2016 — No Q&A session on Thursday (Holiday Break)
CR1 Module 4: Subject Recruitment, Retention, and Follow up process Clinical, Screening, Randomization, and Source Document Entry, Case Report Form (CRF) Entry from Source, AE/SAE, and Protocol Deviation Records and Reporting
- Subject Recruitment, Retention, and Follow up process
- Discuss various recruitment methods
- Strategies to retain subjects & address lost to follow-up
- Common types of bias in Epidemiological studies (case-control, cohort)
- Describe bias in clinical trials (i.e., protocol deviations) how to avoid/address them
- Clinical, Screening, Randomization, and Source document entry,
- Case Report Form (CRF) entry from Source
- AE/SAE and Protocol Deviation records and reporting
Week Five: November 29, 2016
CR1 Module 5: Compliance with Protocols, Monitoring Visits and Drug Inventory Management
- Compliance with Sponsor
- Compliance with Protocol
- Compliance with Monitoring Visits
- Drug Inventory Management
CR1 Module 6: Investigator Regulatory Site File Maintenance and Subject and Site Level Protocol Function Log entry
- Investigator Regulatory Site File Maintenance and Subject and Site Level Protocol Function Log entry
- Coordinator Toolbox What to Include
- Propose rules for a successful coordinator
- Discuss the need for tools by the coordinator/study team during the conduct of a clinical trial
- Present examples of logs/documents to assist the study team
- Essential Documents (ED)
- Understand the importance and purpose of maintaining the essential documents
- Discuss the essential documents that must be present at the Investigator or the Sponsor site before the start of a trial, during the conduct of a trial, and after the completion of a trial
- Elaborate on the Good Clinical Practice documents
- Discuss the Trial Master Files and its contents
- Discuss the Regulatory Binder and its contents
Week Six: December 6, 2016
CR1 Module 7: Sponsor, FDA-Audit, Inspection Preparedness, Drug Return and Records Retention Function, and Site Close Out Responsibilities
- Sponsor / FDA-Audit / Inspection preparedness
- To learn FDA GCP and FDA viewpoint on sponsor responsibilities
- To understand role of FDA in audit and inspection of clinical trial
- To plan for FDA Inspection
- To know what is data inspection process
- Drug Return
- Records retention function
- Site Close out responsibilities
– Mid Term Quiz –
Part 2: Clinical Data Management / Oracle Clinical
Week Seven: December 13, 2016
CDM Module 1: Introduction to Clinical Data Management and Data Management Plan
- Introduction to Clinical Data Management
- Develop and understand the overview of the Drug Development Process
- Understand the importance of CDM in the clinical research process
- Identify clearly, the various clinical data management processes
- Understand the various methods of data acquisition/data capture
- Identify the various methods of data entry based on the data capture instrument being used
- Develop a basic understanding of various standards used in CDM
- Understand the different job profiles in clinical data management and the important activities performed within each job role
- Data Management Plan
- Understand the importance of a Data Management Plan (DMP)
- Know the documents from which the DMP can be prepared
- Identify the various Elements of the DMP
- Understand the Process of Development and Review of DMP
Week Eight: December 20, 2016
CDM Module 2: Standard Operating Procedures and CDM Documentation Overview
- Standard Operating Procedures
- Understand the importance of SOPs in CDM
- Identify the various sections of a SOP document and its contents
- Understand the best practices and standards used in creating an SOP
- Enlist the various SOPs used in Clinical data management and the contents of each
- CDM Documentation Overview
- Enumerate the various essential documents in clinical trials
- Understand the contents of various essential documents
- Enumerate the various documents created and maintained during the management of clinical data
CDM Module 3: Forms Management Data Privacy and GCDMP, 21 CFR Part 11, HL7 and HIPAA Standards
- Forms Management Data Privacy
- Understand the various attributes and importance of data privacy
- Identify some Legislations and Regulatory guidelines for data privacy
- Identify Focus areas for achieving Data Privacy
- Understand the Minimum standards and Best practices in Data Privacy
- GCDMP, 21 CFR Part 11, HL7 and HIPAA standards
- Understand the various standards used in clinical data management
- Define GCDMP, HL7 and HIPAA standards
- Elaborate on the various sections of the 21 CFR Part 11 Standards
Week Nine: December 27, 2016
CDM Module 4: Trial Metrics and Database Closure
- Trial Metrics
- Understand the importance of trial metrics and the various factors affecting it
- Enlist the metrics related to time, cost and quality
- Identify the characteristics of meaningful metrics and the various metrics drivers
- Enumerate the advantages of collecting metrics and the process of generating metrics for clinical trials
- Database Closure
- Understand the concept of Database closure
- Know the process of database closure and pre-closure activities
- Identify the various types of Analysis conduct prior to database closure
- Understand the various types of Database locks and their significance
- Understand Minimum Standards and Best Practices to be adopted for Database closure and methods for reducing time to database lock
Week Ten: January 3, 2017
OC Module 1: Oracle Clinical Overview, Navigation and Subsystems and Planning and Designing a Study
- Oracle Clinical Overview
- Understand the workflow of a clinical data management system
- Obtain an overview of the Oracle Clinical subsystems Know in brief, the functionality of various modules under each subsystem
- Understand CRF Design objects (building blocks of a CRF in Oracle clinical)
- Adapt to basic form and system functions
- Navigation and Subsystems Planning
- Designing a Study
Week Eleven: January 17, 2017
OC Module 2: Global Library – DVGs, Questions and Question Groups and Definition Subsystem – DCMs and DCIs, Generating Data Entry screens
- Global Library – DVGs, Questions and Question Groups
- Definition Subsystem – DCMs and DCIs, Generating Data Entry screens
- Creating Annotated CRF
- Designing GLIB objects (DVGs, Questions, Question Groups)
- Activating Study Level objects (DCMs and DCIs)
- CRF objects Attributes in Oracle Clinical
- Generating, Editing and Testing Data Entry screens
Week Twelve: January 24, 2017
OC Module 3: Validation and Derivation Procedures and Production Data Entry
- Validation and Derivation
- Procedures and Production Data Entry
- Completed Physical examination CRF
- Data Entry and Review Guidelines document OC Module 4: Discrepancy and DCF Management
- Discrepancy and DCF Management
- Different types of discrepancies
- Managing discrepancies
- Reviewing discrepancies
- Issuing DCFs and resolving DCFs
Week Thirteen: January 31, 2017
– Final Exam –
Bonus Week: February 9, 2017
Final Week for Course Completion
Instructors
Durdant Dave
Dr. Durdant Dave holds MBBS and MS (Ophthalmology) degrees, and has over twenty years of experience in Clinical Trials and Research. He is well versed in Clinical Trial phases II through IV. His experience spans the therapeutic areas of Ophthalmology, Oncology, Cardiology, Psychiatry, General Medicine, and Pain Management.
Kamal Akhtar
Kamal Akhtar manages the content and execution of Clinical Data Management and Oracle Clinical programs at Sollers. He is an expert in Clinical Data Management, Enterprise Applications for CDM, and Bio-Informatics Applications. He has more than six years of pharmaceutical industry experience and he has also published an e-book titled, Clinical Data Management — A Beginners Guide.