Company Name : Clinical Data Standards (clinicaldatastandards.com)
Location : Hyderabad
Courses Offered : Clinical Data management, SAS Clinical Training
https://web.archive.org/web/20141013100627/http://clinicaldatastandards.com/coursesoffered.html
1.Clinical Data management
Introduction to clinical Research:
Drug Development Process
Phase trails
Systems used in clinical
Career and Scope in clinical
Law, Guidelines,Regulations:
ICH-GCP
21 CFR 11
Applicable CFR Regulations
E6, E9, E2 Guidelines
Persons,committees,Regulatory responsibilities:
Investigator
Monitor
CRC
Clinical Nurse
IRB
FDA
DCGI
General:
PK, PD
Informed Consent Process
IB
SOP
DMP
Practical :
Data base setup:
Understanding protocol
pCRF Design
Visit structure
Standard form and TA forms
Elements of design
P-CRF review and quality marking
E-CRF Specification:
Important elements of e-CRF
Understanding data base
Add entry or Log forms
E-CRF review
Data Validation:
Writing edit checks
Conditionals
Derivations and calculation
Simple checks
Complex checks
DVS review
Data Review :
Data cleaning:
Data Collection
Data entry single and double
Query Management
Medical coding
SAE and Lab reconciliation
Audit and inspections
Vendor management
External data management
Data base lock
Data base freeze
Pharmacovigilance
CDISC STANDARDS:
SDTM
Understanding Annotation
Writing mapping specification
Classification of data
Domains
Variables
ODM
ADaM
CDASH
ECTD
QC PROCESS
UAT PROCESS
2.One Month Training Program on SAS (Clinical)
Course Duration : 31 Days
Eligibility: Bachelor’s, Master’s, or a Ph.D. in a Science or Allied Health Field; OR Healthcare Professional Medical Technologist, B.sc, M.sc life sciences. Pharmacy, Biotech, Computer.
3.One Month Training Program in CRF designing
4.One Month Training program in SDTM
5.One Month program in Pharmacovigilance
6.One Month Program in Validation
7.One Month Training Program on CDASH.
8.One Month Training Program on Trial designing Model
9.One Month Training Program on TLG Creation for SAS Programmers
10.One Month Training Program on SDTM Datasets for SAS Programmers
11.One month Training Program on Validation Listing for SAS Programmers
Contact us :
Clinical Data Standards (CDS)
6-3-789,705,7th floor, Above RS Brothers building, Pavani prestage,
Ameerpet,Hyderabad-500016
Andhra Pradesh.
Ameerpet, Hyderabad – 500016