Clinical Data Management

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


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


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


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


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


CLINICAL DATABASE SEARCH


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

Documents

Clinical Data Management