CDM+Notes 1

Download as pdf or txt
Download as pdf or txt
You are on page 1of 7

The CDM Process

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.

Review and finalization of study documents

The protocol is reviewed from a database designing perspective, for


clarity and consistency. During this review, the CDM personnel will
identify the data items to be collected and the frequency of collection
with respect to the visit schedule. A Case Report Form (CRF) is designed
by the CDM team, as this is the first step in translating the protocol-
specific activities into data being generated. The data fields should be
clearly defined and be consistent throughout. The type of data to be
entered should be evident from the CRF. Along with the CRF, the filling
instructions (called CRF Completion Guidelines) should also be provided
to study investigators for error-free data acquisition. CRF annotation is
done wherein the variable is named according to the SDTMIG or the
conventions followed internally. Annotations are coded terms used in
CDM tools to indicate the variables in the study.

Based on these, a Data Management Plan (DMP) is developed. DMP


document is a road map to handle the data under foreseeable
circumstances and describes the CDM activities to be followed in the
trial. A list of CDM activities is provided in Table 1. The DMP describes
the database design, data entry and data tracking guidelines, quality
control measures, SAE reconciliation guidelines, discrepancy
management, data transfer/extraction, and database locking guidelines.
Along with the DMP, a Data Validation Plan (DVP) containing all edit-
checks to be performed and the calculations for derived variables are
also prepared. The edit check programs in the DVP help in cleaning up
the data by identifying the discrepancies.
Table 1
List of clinical data management activities

Database designing

Databases are the clinical software applications, which are built to


facilitate the CDM tasks to carry out multiple studies. Generally, these
tools have built-in compliance with regulatory requirements and are
easy to use. “System validation” is conducted to ensure data security,
during which system specifications user requirements, and regulatory
compliance are evaluated before implementation. Study details like
objectives, intervals, visits, investigators, sites, and patients are defined
in the database and CRF layouts are designed for data entry. These entry
screens are tested with dummy data before moving them to the real data
capture.

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

Data validation is the process of testing the validity of data in accordance


with the protocol specifications. Edit check programs are written to
identify the discrepancies in the entered data, which are embedded in
the database, to ensure data validity. These programs are written
according to the logic condition mentioned in the DVP. These edit check
programs are initially tested with dummy data containing discrepancies.
Discrepancy is defined as a data point that fails to pass a validation
check. Discrepancy may be due to inconsistent data, missing data, range
checks, and deviations from the protocol. In e-CRF based studies, data
validation process will be run frequently for identifying discrepancies.
These discrepancies will be resolved by investigators after logging into
the system. Ongoing quality control of data processing is undertaken at
regular intervals during the course of CDM.

Discrepancy management

This is also called query resolution. Discrepancy management includes


reviewing discrepancies, investigating the reason, and resolving them
with documentary proof or declaring them as irresolvable. Discrepancy
management helps in cleaning the data and gathers enough evidence for
the deviations observed in data. Almost all CDMS have a discrepancy
database where all discrepancies will be recorded and stored with audit
trail.

Based on the types identified, discrepancies are either flagged to the


investigator for clarification or closed in-house by Self-Evident
Corrections (SEC) without sending DCF to the site. The most common
SECs are obvious spelling errors. For discrepancies that require
clarifications from the investigator, DCFs will be sent to the site. The
CDM tools help in the creation and printing of DCFs. Investigators will
write the resolution or explain the circumstances that led to the
discrepancy in data. When a resolution is provided by the investigator,
the same will be updated in the database. In case of e-CRFs, the
investigator can access the discrepancies flagged to him and will be able
to provide the resolutions online.
Discrepancy management (DCF = Data clarification form, CRA = Clinical Research Associate,
SDV = Source document verification, SEC = Self-evident correction)

The CDM team reviews all discrepancies at regular intervals to ensure


that they have been resolved. The resolved data discrepancies are
recorded as ‘closed’. This means that those validation failures are no
longer considered to be active, and future data validation attempts on
the same data will not create a discrepancy for same data point. But
closure of discrepancies is not always possible. In some cases, the
investigator will not be able to provide a resolution for the discrepancy.
Such discrepancies will be considered as ‘irresolvable’ and will be
updated in the discrepancy database.

Medical coding

Medical coding helps in identifying and properly classifying the medical


terminologies associated with the clinical trial. For classification of
events, medical dictionaries available online are used. Technically, this
activity needs the knowledge of medical terminology, understanding of
disease entities, drugs used, and a basic knowledge of the pathological
processes involved. Functionally, it also requires knowledge about the
structure of electronic medical dictionaries and the hierarchy of
classifications available in them. Adverse events occurring during the
study, prior to and concomitantly administered medications and pre-or
co-existing illnesses are coded using the available medical dictionaries.

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.

Roles and Responsibilities in CDM

In a CDM team, different roles and responsibilities are attributed to the


team members. The minimum educational requirement for a team
member in CDM should be graduation in life science and knowledge of
computer applications. Ideally, medical coders should be medical
graduates. However, in the industry, paramedical graduates are also
recruited as medical coders. Some key roles are essential to all CDM
teams. The list of roles given below can be considered as minimum
requirements for a CDM team:

• 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.

You might also like

pFad - Phonifier reborn

Pfad - The Proxy pFad of © 2024 Garber Painting. All rights reserved.

Note: This service is not intended for secure transactions such as banking, social media, email, or purchasing. Use at your own risk. We assume no liability whatsoever for broken pages.


Alternative Proxies:

Alternative Proxy

pFad Proxy

pFad v3 Proxy

pFad v4 Proxy