CDM+Notes 1
CDM+Notes 1
CDM+Notes 1
The CDM process, like a clinical trial, begins with the end in mind. This
means that the whole process is designed keeping the deliverable in
view. As a clinical trial is designed to answer the research question, the
CDM process is designed to deliver an error-free, valid, and statistically
sound database. To meet this objective, the CDM process starts early,
even before the finalization of the study protocol.
Database designing
Data collection
Data collection is done using the CRF that may exist in the form of a
paper or an electronic version. The traditional method is to employ
paper CRFs to collect the data responses, which are translated to the
database by means of data entry done in-house. These paper CRFs are
filled up by the investigator according to the completion guidelines. In
the e-CRF-based CDM, the investigator or a designee will be logging into
the CDM system and entering the data directly at the site. In e-CRF
method, chances of errors are less, and the resolution of discrepancies
happens faster.
CRF tracking
The entries made in the CRF will be monitored by the Clinical Research
Associate (CRA) for completeness and filled up CRFs are retrieved and
handed over to the CDM team. The CDM team will track the retrieved
CRFs and maintain their record. CRFs are tracked for missing pages and
illegible data manually to assure that the data are not lost. In case of
missing or illegible data, a clarification is obtained from the investigator
and the issue is resolved.
Data entry
Data entry takes place according to the guidelines prepared along with
the DMP. This is applicable only in the case of paper CRF retrieved from
the sites. Usually, double data entry is performed wherein the data is
entered by two operators separately. The second pass entry (entry made
by the second person) helps in verification and reconciliation by
identifying the transcription errors and discrepancies caused by illegible
data. Moreover, double data entry helps in getting a cleaner database
compared to a single data entry. Earlier studies have shown that double
data entry ensures better consistency with paper CRF as denoted by a
lesser error rate.
Data validation
Discrepancy management
Medical coding
Database locking
After a proper quality check and assurance, the final data validation is
run. If there are no discrepancies, the SAS datasets are finalized in
consultation with the statistician. All data management activities should
have been completed prior to database lock. To ensure this, a pre-lock
checklist is used, and completion of all activities is confirmed. This is
done as the database cannot be changed in any manner after locking.
Once the approval for locking is obtained from all stakeholders, the
database is locked, and clean data is extracted for statistical analysis.
Generally, no modification in the database is possible. But in case of a
critical issue or for other important operational reasons, privileged users
can modify the data even after the database is locked. This, however,
requires proper documentation and an audit trail must be maintained
with sufficient justification for updating the locked database. Data
extraction is done from the final database after locking. This is followed
by its archival.
• Data Manager
• Database Programmer/Designer
• Medical Coder
• Clinical Data Coordinator
• Quality Control Associate
• Data Entry Associate
The data manager is responsible for supervising the entire CDM process.
The data manager prepares the DMP, approves the CDM procedures and
all internal documents related to CDM activities. Controlling and
allocating the database access to team members is also the responsibility
of the data manager. The database programmer/designer performs the
CRF annotation, creates the study database, and programs the edit
checks for data validation. He/she is also responsible for designing of
data entry screens in the database and validating the edit checks with
dummy data. The medical coder will do the coding for adverse events,
medical history, co-illnesses, and concomitant medication administered
during the study. The clinical data coordinator designs the CRF, prepares
the CRF filling instructions, and is responsible for developing the DVP
and discrepancy management. All other CDM-related documents,
checklists, and guideline documents are prepared by the clinical data
coordinator. The quality control associate checks the accuracy of data
entry and conducts data audits. Sometimes, there is a separate quality
assurance person to conduct the audit on the data entered. Additionally,
the quality control associate verifies the documentation pertaining to the
procedures being followed. The data entry personnel will be tracking the
receipt of CRF pages and performs the data entry into the database.
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