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Survey for CDM
Understanding of activities performed in CDM & BS Units
If you are a clinical research professional not exposed to CDM & BS directly, kindly spare a few minutes in filling the survey questionnaire so that we can assess your perception / awareness about activities / tasks performed in CDM & BS units.
Our aim is to bridge the knowledge gap that may exist in the general understanding of tasks like, process of cleaning and / validating data, coding of medical terms like adverse events, medical history and concomitant medications, minimizing data queries and also in statistical analysis of data generated in clinical trials. It will also help us to design and organize appropriate workshops and seminars in order to systematically minimize the knowledge gap, if any. .
Please complete this form online and submit. We request you to kindly submit before
September 15, 2008
.
ISCR
, would sincerely like to
thank you
for participating and providing details for this survey.
* Required Information
Survey to Assess Awareness in Clinical Data Management & Biostatistics
Name:
ISCR Member:
Yes
No
*
Qualification:
Name of Organisation:
Type of Organisation:
ACADEMIC INSTITUTION / UNIVERSITIES / COLLEGES
BIOTECHNOLOGY COMPANY
CENTRALISED LABORATORY
CONTRACT RESEARCH ORGANISATION
HOSPITAL
MEDICAL DEVISE/DIAGNOSIS/IMAGING FIRM
PHARMACEUTICAL COMPANY
STUDENT
REGULATORY AGENCY
OTHER for Other please specify,
*
Designation:
Your Role:
BIOSTATISTICIAN
CLINICAL RESEARCH MONITORING
DATA MANAGEMENT PERSONNEL
INVESTIGATOR
MEDICAL MONITOR/ADVISOR
PHARMACOVIGILANCE
PROJECT MANAGER
SITE COORDINATOR
STATISTICAL PROGRAMMER
OTHER for Other please specify,
Experience:
Total:
Year(s)
Month(s)
Clinical Research:
Total:
Year(s)
Month(s)
(This should include experience in various areas
such as Biostatistics clinical, data management, Pharmacovigilance etc)
Area:
Biostatistics:
Total:
Year(s)
Month(s)
Clinical:
Total:
Year(s)
Month(s)
Data Management:
Total:
Year(s)
Month(s)
Pharmacovigilance:
Total:
Year(s)
Month(s)
Other, specify
:
Total:
Year(s)
Month(s)
Do you treat Clinical data management and Biostatistics is two different faculty?
Yes
No
Are you interested in knowing more about Clinical Data Management?
Yes
No
List the tasks/activities which you know/heard about/worked in Clinical Data management?
Activity
Don’t Know
Know
Know Little
Would Like to Know
1. Database Design
2. Database Programming
3. Case Report Form Logging
4. Case Report Form Tracking
5. Electronic Data Capture (eDC)
6. Remote Data Capture (RDC)
7. Double Data Entry
8. Data Cleaning/Validation
9. Medical Coding
10. External Data Import
11. Data Transfer
12. Serious Adverse Event Reconciliation
13. Quality Control
14. Quality Assurance
15. Database Lock
16. Any Other (Please specify)
17. Any Other (Please specify)
18. Any Other (Please specify)
19. Any Other (Please specify)
20. Any Other (Please specify)
List the tasks/activities which you would like to know more about Clinical Data management?
1.
2.
3.
4.
5.
6.
7.
8.
Are you interested in knowing more about Biostatistics?
Yes
No
List the tasks/activities which you have know/heard/worked in Biostatistics?
Activity
Don’t Know
Know
Know Little
Would Like to Know
1. Design of Clinical Trial
2. Statistical Inputs to Study Protocol
3. Sample Size Calculation
4. Randomisation
5. Statistical Analysis Plan
6. Statistical Programming
7. Statistical Analysis and Interpretation
8. Statistical Report Generation
9. Statistical Inputs to Clinical Study Report
10. Any Other (Please specify)
11. Any Other (Please specify)
12. Any Other (Please specify)
13. Any Other (Please specify)
14. Any Other (Please specify)
15. Any Other (Please specify)
16. Any Other (Please specify)
17. Any Other (Please specify)
18. Any Other (Please specify)
19. Any Other (Please specify)
20. Any Other (Please specify)
List the tasks/activities which you would like to know more about Biostatistics?
1.
2.
3.
4.
5.
6.
7.
8.
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