Adithyaelearning provides SAS CDM Online Training to the candidates having knowledge in the SAS. Throughout this course the participants will become qualified on the Clinical programming models as well as their usage in field of clinical research. The center areas for the course incorporate data integration, data manipulation, data listings production, figures and tables as per Statistical Examination Plan, as well as generation of reports and graphs. Besides this participants can be trained based on fundamental principles as well as concepts in the statistical methodology as well as clinical trials.

1. CLINICAL DATA
MANAGEMENT
SAS CDM Online Learning

2. LEARNING
OBJECTIVES
End of the session attendees should learn:
1. What is Clinical trial?
2. Types of Clinical trials
3. Phases in Clinical trials
4. Process in Clinical trial
5. MultidisciplinaryTeams in ClinicalTrials

3. What isClinical
Trial?
Any investigation in human subjects intended
to discover or verify the clinical,
pharmacological and/or other
pharmacodynamic effects of an investigational
product(s), and/or to identify any adverse
reactions to an investigational product(s),
and/or to study absorption, distribution,
metabolism, and excretion of an
investigational product(s) with the object of
ascertaining its safety and/or efficacy. The
terms clinical trial and clinical study are
synonymous.
Ref: ICH-GCP E6(R2)

4. What are the
objectives of
conducting
clinical trial?
Intervention trials determine
whether experimental
treatments or trials are safe and
effective under controlled
environments
Observation trials address
health issues in large groups of
people in natural settings.

5. WhenClinical
Trials are
conducted?
When the laboratory and animal
studies yield the most promising
results of the intervention, those
results are tested by clinical trials
in human.

6. Types of
ClinicalTrials
1. TreatmentTrials
2.PreventionTrials
3. DiagnosticTrials
4.ScreeningTrials
5. Quality of LifeTrials
6.GeneticTrials
7. EpidemiologicalTrials

7. Treatment
Trials
Generally involves an intervention such as
- NewTreatment
- New combination of drug
- New Psychotherapy,
- New devices,
- New approaches to surgery
- New radiation therapy

8. Prevention
Trials
Find better ways to prevent disease in people and to
prevent disease recurrence using
 Medicines
 Vaccines
 Vitamins
 Minerals
 Life style changes

9. Diagnostic
Trials
The practice of looking for better ways to
identify a particular disorder or condition.
 To find better tests for diagnosis of a disease
 To find better procedures for diagnosis of a disease

10. Screening
Trials
To find out the best way to detect certain
Diseases, disorders or health conditions

11. Quality of Life
Trials
Also called Supportive care trials
 Often employed for the chronically ill patients
 They explore the ways to improve comfort and
 to improve the quality of life

12. GeneticTrials
Aim to improve the prediction of disorders by
 identifying and understanding how genes and
illnesses may be related.
Research in this area may explore ways
 in which a person’s genes make him or her
more or less likely to develop a disorder.
 This may lead to development of tailor-made
treatments based on a patient’s genetic make-
up.

13. Epidemiologic
alTrials
Seek to identify
 The patterns,
 The causes, and
 The control of disorders
in groups of people.

14. Phases of
ClinicalTrials
Phase -I trials
Phase -II trials
Phase -III trials
Phase -IV trials

15. Phase ITrials
 FIRSTTIMETESTING
 IN A SMALL GROUP OF 20-80
PURPOSE:
 TO EVALUATE SAFETY
 TO DETERMINE A SAFE DOSAGE RANGE
 INDENTIFY SIDE EFFECTS

16. Phase IITrials
 TESTED IN LARGE GROUP OF 100-300
PEOPLE
PUROSE ISTO FURTHER EVALUATE
 ASCERTAIN IFTHETREATMENT IS EFFECTIVE
 FURTHER EVALUATE SAFETY

17. Phase IIITrials
 STILL LARGE GROUP 1000-3000 PEOPLE ARE
TESTED
PURPOSE IS TO CONFIRM
 ITS EFFECTIVENESS
 MONITOR SIDE EFFECTS
 COMPARE WITH COMMONLY USED
TREATMENTS
 TO GATHER INFORMATION REGARDING
SAFE USE

18. Phase IVTrials
POST MARKETTING STUDIES- which are
conducted after a treatment is approved for use
TO KNOW ABOUTTREATMENT’S or DRUG’S
 RISKS
 BENEFITS
 OPTIMAL USE

19. ClinicalTrial
Phases
The science
we have today
(literature, proprietary
studies, etc.)
Clinical evidence to
support the new
treatment/drug
Select
Safety and
efficacy on
small scale /
specific target
Safety and
efficacy on
large scale /
global target
Preclinical and exploratory clinical studies to select the new
entity/treatment, propose the right dosing and receive first
indications for the later clinical study hypotheses
Small pilot studies to show that the new
ingredient seems to be safe and that it
works and how it works
Large efficacy studies to
prove safety and the
clinical benefit
Post MarketingTrials

20. Process
Overview of
ClinicalTrials
Phases within a ClinicalTrial

21. Multidisciplina
ryTeams in
ClinicalTrials
1. Clinical Investigator
2. Site Coordinator
3. Trial Pharmacists
4. Biostatistician
5. Lab Coordinator
6. Project Manager
7. Clinical Research Associate/ Manager
8. Monitor
9. Ethics committee
10. Regulatory affairs
11. Clinical Data Management
12. Pharmacovigilance
13. Clinical Supply
14. QualityAuditor

22. Summary of
what we learnt
 ClinicalTrial /Study
 Types of ClinicalTrials
 Phases of ClinicalTrials
 Process in ClinicalTrials
 Team involved in ClinicalTrials

23. NextSession
 Regulatory Guidelines including data privacy and
protection
 ICH-GCP
 21 CFR Part 11
 HIPAA
 Protocol (Study Plan)