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Clinical Data Management
1.
Clinical data management
Made by:- ShrayJali
2.
3.
Serves as a
basis for submission, approval, labelling and marketing of a compound
4.
Sources:
5.
Subject-investigator interaction at
sites (e.g. Remote Data Capture (RDC) technology)
6.
Laboratories
7.
Directly from subjects
and partners (e.g. Contract Research Organizations - CROs)
8.
9.
Health Authority/Ethics Committee
approval is necessary
10.
Often a clinical
trial is managed by an outsourced partner such as a CRO
11.
12.
13.
Clinical trial data
gathered at the investigator site in the case report form are stored in the CDMS
14.
15.
Standard dictionaries of
these terms can be loaded into the CDMS
16.
Some systems allow
for the storage of synonyms to allow the system to match common abbreviations and map them to the correct termExample: ASA could be mapped to Aspirin
17.
18.
Ensures that human
error will be kept to a minimum
19.
Software systems of
this type also file data and screen data for any illogical patterns
20.
21.
22.
23.
High data security
24.
Affordable rates
25.
Efficient validation procedures
26.
Advanced technology
27.
Flexibility
28.
29.
Also known as
metadata (Data table restricted to information about data elements) repository
30.
31.
Clinical database search
32.
Dictionary management
33.
34.
Get an accurate,
real-time view of clinical trial forecasts and budgets
35.
Effectively use critical
information and collaboratively assess performance.
36.
Aggregation of data
and its Dissemination via an open framework
37.
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