clinical data management
DESCRIPTION
TRANSCRIPT
CLINICAL DATA MANAGEMENT
MADE BY:-SHRAY JALI
CLINICAL DATA Most valuable asset to a pharmaceutical company
Serves as a basis for submission, approval, labelling and marketing of a compound
Sources: Subject-investigator interaction at sites (e.g. Remote Data
Capture (RDC) technology) Laboratories Directly from subjects and partners (e.g. Contract Research Organizations - CROs)
CLINICAL TRIALS
Conducted to allow safety and efficacy data to be collected for new drugs or devices
Health Authority/Ethics Committee approval is necessary
Often a clinical trial is managed by an outsourced partner such as a CRO
Includes measurements like vital signs, amount of study drug in the blood, and whether the patient's health gets better or not & then the data is sent to the trial sponsor who analyses the pooled data using statistical tests
CLINICAL TRIALS
CLINICAL DATA MANAGEMENT
Used in clinical research to manage the data of a clinical trial
Clinical trial data gathered at the investigator site in the case report form are stored in the CDMS
To reduce the possibility of errors due to human entry, the systems employ different means to verify the entry such as double data entry
CLINICAL DATA MANAGEMENT
Coding of data: adverse event terms and medication names
Standard dictionaries of these terms can be loaded into the CDMS
Some systems allow for the storage of synonyms to allow the system to match common abbreviations and map them to the correct term
Example: ASA could be mapped to Aspirin
CLINICAL DATA MANAGEMENT
Data gathered during clinical trials is stored within a CDMS
Ensures that human error will be kept to a minimum
Software systems of this type also file data and screen data for any illogical patterns
Helps researchers to scrutinize their material. Clinical software has largely replaced manual inputting of data. Most programs of this type include spreadsheet
CLINICAL DATA MANAGEMENT
DOUBLE DATA ENTRY
Method of quality control, very useful in catching and correcting typographical errors
Also known as Two pass verification
Special features of our Double Keyed Data Entry Service: High accuracy High data security Affordable rates Efficient validation procedures Advanced technology Flexibility Duplicate check identification
DICTIONARY MANAGEMENT
Stores the structure of the structure of the clinical data tables so that they can be accessed correctly
Also known as metadata (Data table restricted to information about data elements) repository
e.g. MedDRA for adverse events and WHO Drug for medications
DICTIONARY MANAGEMENT
CLINICAL DATABASE SEARCH
DICTIONARY MANAGEMENT
To find ways to cut both costs and time from the clinical development process
Get an accurate, real-time view of clinical trial forecasts and budgets
Effectively use critical information and collaboratively assess performance.
Aggregation of data and its Dissemination via an open framework
To limit error, improve control, enhance visibility, and boost accountability
NEED FOR CDMS