CDM

CDM- Data Archiving

Clinical Data Archiving

Introduction:
Clinical data archiving includes the planning, implementing and maintaining of a repository of documents and records that contain clinical data together with any interpretive information from a clinical trial.

The clinical data archive should include a centralized table of contents for all studies.
Clinical trial documents must be maintained for a period of two years after completion of Clinical trials

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By |November 17th, 2014|CDM|0 Comments

Serious Adverse Event(SAE) Reconciliation

Reconciliation of the Serious Adverse Event
Serious Adverse Event data Reconciliation is the comparison of key safety data between two data bases. (Clinical data base defined as a closed data base and a safety data base defined as an open data base.
Clinical data base defined as a closed since it can receive data only for a very short period of time. A safety data base defined as an open data base since it continues receive new SAE’s or updates of pre-existing SAE’s. […]

By |November 16th, 2014|CDM|0 Comments

CDM-Database Locking and Freezing

Database Locking or Closing the study database is fundamental in preventing inadvertent or unauthorized changes once the final analysis and reporting of the data have begun. Although important in open-label studies, it is even more critical in randomized trials in order to preserve the integrity of the randomization process once the blind has been broken. A well-defined process for closing a database and change control procedures in the event of the necessity of reopening the database are essential.
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By |November 16th, 2014|CDM|0 Comments

Discrepancy Management (Query Management)

Discrepancy management is also called as query management, is a process of cleaning subject data in the Clinical Data Management Systems(CDMS). Discrepancies are raised/ created during data entry and data validation.
Where data entered does not pass validation rules then a data query may be issued to the investigative site where the clinical trial is conducted to request clarification of the entry. Data queries must not be leading (i.e. they must not suggest the correction that should be made).
For electronic CRFs only the site staff with appropriate access may modify data entries. For paper CRFs, the clinical data manager applies the data query response to the database and a copy of the data query is retained at the investigative site.
Query management is done via Data Clarification Form (DCF). […]

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Clinical Safety Data Management

CLINICAL SAFETY DATA MANAGEMENT
EXPEDITED REPORTING

Adverse Event:  An Adverse Event (AE) is any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. Inter-current illness or injuries should be regarded as adverse events. Abnormal results of diagnostic procedures are considered to be adverse events, if the abnormality;

Results in study with drawl
Is associated with a serious adverse event
Is associated with clinical signs or symptoms
Leads to additional treatment or to further diagnostic tests
Is considered by the investigator to be of clinical significance
Which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of diseases or for modification of physiological function.

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By |November 16th, 2014|CDM|0 Comments

CDM- QA & QC

Pharmaceutical companies recognize the benefits of carefully managing the quality of data from their drug development and clinical trials. To ensure clinical data accuracy and integrity, it is necessary to thoroughly review these data, to assess the validity of outlying data points, and to carefully document query identification and resolution throughout a study’s duration. Maintaining accuracy and quality throughout a clinical study is a continual, dynamic process. Although study requirements are carefully set forth initially in detailed documents such as an approved clinical protocol, a data management plan, and an accompanying project plan, expectations and requirements can change during a study. This ongoing process requires revising mechanisms and communicating these revisions clearly to all investigators and support staff. […]

By |November 16th, 2014|CDM|0 Comments

CDM- Data Coding

Data coding: Coding involved the selection of a word or phrase from a medical terminology and entry of the corresponding code (numeric, alphabetic or alphanumeric) onto a database.
Coding was necessary because it required little space for storage on the database and made searching easier.
Types of Coding:
Auto Coding: Auto-encoder codes 60% of the verbatim terms automatically. The auto-encoder helps in consistent coding, without the manual re evaluation of previously coded terms. Encoders are system dependent and proper training and usage of these tools is highly recommended for the users. An auto encoder is useful when coding adverse events and medications utilizing dictionaries with large amount of entries. […]

By |November 16th, 2014|CDM|0 Comments

CDM Data validation

CDM Data validation

Data cleaning or validation is a collection of activities used to assure the validity and accuracy of the data.

Data cleaning may include manual review of the data, or computer checks designed to identify inaccurate or invalid data using ranges, completeness, protocol violations and consistency checks.

Data cleaning include the following: […]

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CDM- Data Entry

Data Entry
The process of entering data into a computerized database or spreadsheet. Data entry can be performed by an individual typing at a keyboard or by a machine entering data electronically.
The data entry process should address the data quality needs of the trial. Commonly used data entry processes include the following: […]

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Clinical Data Capture Methods

Clinical Data Capture Methods:
Definition:
It is the collection of clinically significant data by the Investigator/s for clinical trials on behalf of the Sponsor in a sequential manner (per protocol) to process the same and generates reports at a later stage for submissions to regulatory authorities for various purposes.
Clinical Data Capture: 
These are the procedures for gathering and recording data from or related to subjects in the study. The capture methods are of two types:  Paper based OR Electronic Data Capture (EDC). Promise of increased efficiency has led to increasing movement toward implementation of the electronic medical record and to computerized automation in general […]

By |November 16th, 2014|CDM|0 Comments