How to develop a clinical data management strategy

During Phase III clinical data management, approximately 3.6 million data sets are collected, which is three times the amount collected a decade ago. The Phase III procedure has remained unchanged for decades.The procedure begins before a medicine or therapeutic approach is approved, can last for years, and can involve up to three thousand individuals.

Table of Contents

Quality control in clinical data management employs extensive drug development programs centered on rare diseases and genetic data, all of which contribute to clinical data management. This manual explains user acceptability testing in clinical data management, edit checks in clinical data management, and the definition of clinical data management. Let’s start by defining what clinical data management is.

What is the definition of management of clinical data?

Clinical data management (CDM) is a set of methodologies used to manage data collected during medical research. Its objective is to ensure the authenticity and dependability of data, as well as its compliance with company and government regulations. The CDM procedure also contributes to the maintenance of uniformity among clinical trial participants:

Sponsors: These are the pharmaceutical companies, government agencies, and other organizations responsible for initiating, supervising, and funding the trial.
Control research organizations (CROs) are organizations contracted by the sponsors to carry out the design and implementation of the study.
Sites: Locations in charge of managing the acquisition of information from trial participants.

Clinical data management is indispensable for determining the efficacy and safety of any given therapy, diagnosis, or disease prevention technique. If done correctly, it can significantly reduce the amount of time required to introduce a new medical product.

Steps and procedures a clinical data management

Initial CDM activities commence during the design phase of a clinical trial, when a protocol outlining the objectives and methodologies of the study is created. Typical divisions of data-related duties include:

A Clinical Data Manager (CDM): the duties and responsibilities of a clinical data manager include overseeing the entire CDM operation and managing the parties involved in the operation.
Someone who deals with databases as a programmer or designer.
Data entry specialists.
A medical coder who employs industry-standard codes to record medical information, such as patient diagnoses, procedures, and complications.

A quality control professional

We will investigate the data management process in the section that follows.

1. Data management strategy design

Plans for data management aid in outlining the CDM lifecycle’s processes, activities, and milestones, as well as their outputs. This document serves as a guide for managing data and minimizing risks. As the trial progresses, it is also crucial to keep everyone informed.

The DMP must be completed as part of the trial’s design prior to enrolling the first participant. This will ensure that data is collected in a standard format and correctly catalogued. The plan will need to be revised as the experiment progresses to account for any new information or circumstances that may have an impact on data management.

2. Electronic case report documents format

A case report form (CRF) is a paper or electronic questionnaire used to collect data from trial participants and submit it to the trial administrators. Each study endeavor has its own document written in accordance with the following standards:

Procedure for testing
Recommendations from the Clinical Data Acquisitions Standards Harmonization (CDASH). The Clinical Data Interchange Standards Consortium develops these standards to facilitate intersectoral communication. For example, suppose CDASH mandates a dd/mm/yyyy format for recording dates.

Data administrators collaborate with a database developer to create data entry displays and electronic case report form (eCRF) layouts. Before a design is finalized, there are typically multiple evaluations iterations.

3. Clinical testing database structure

The information obtained from a clinical trial is recorded and arranged in rows and columns to form a database. Specifically, it is formatted according to CRF requirements. The database stores the structure of case report form questionnaires.

Some information collected from questionnaires can be classified into valuable categories to help reduce the quantity of data stored. Professionals in database design develop procedures for decoding or mapping codes to CRF components. Before databases are released into the production (study) environment, they are evaluated using dummy data in a non-research context.

4. Conduct clinical trials using electronic data capture

It has already been established that CRFs are the primary data collection tool in clinical trials. Typically, clinicians or data entry specialists collect participant data for report forms during office visits. In recent years, medical websites are no longer the primary data collection hub.

Data from paper-based questionnaires must be manually entered into printed forms prior to uploading to the database. Using eCRFS, data is entered into the computer from the outset, and certain sections can be completed automatically by robotic process automation (RPA) systems that receive data from medical devices or EHRs. In any case, the data validation procedure is required for all data entered into the forms and subsequently entered into the clinical database.

5. Verification of sources, anonymization of data, and modification comprise data validation.

Clinical data management validation entails a series of tests designed to detect problems with the data’s veracity, consistency, readability, or integrity. Included are the essential procedures:

Software for proofreading edits

Designers of databases incorporate edit checks into eCRFs, which compare data entered with predefined numerical and logical standards. If this is accomplished, the paper will not contain implausible values. For instance, if the system is configured to handle temperatures in Fahrenheit, a check for the body temperature field may reject any data between 95 and 105.

Source data verification (SDV)

The SDV method compares data entered into a CRF with source documents, such as medical records. The purpose of this procedure is to ensure that an eCRF accurately represents a participant’s profile and contains all pertinent information.

Data anonymization

Prior to being sent to sponsors, clinical data must be de-identified to ensure HIPAA compliance (HIPAA). Protected health information (PHI) must be removed from the document.

6. Locking the database and preserving data

In order to prevent tampering with the data, the database is sealed after the study is complete. The next stage is to hand over the thoroughly cleansed data to the appropriate parties for statistical analysis, reporting, and publication. None of these procedures technically constitutes clinical data management.

Three years is the minimum storage requirement for court documents and evidence. This allows for experimental reconstruction and analysis following the collection of data, which is advantageous for the advancement of knowledge.

Importance of clinical data management

Spreadsheets and other office software are incapable of handling all of the issues associated with healthcare data administration. Clinical data management systems (CDMS), also known as electronic data capture (EDC) systems, are required because they are capable of processing large volumes of documents and are tailored for medical research.

CDMSs can be customized for use in psychiatric research, clinical trials of medical devices, and medication development, among other fields. They share the same core functionality, which includes the most fundamental facets of data administration.

1. Observance of 21 CFR part 11

Title 21 of the CFR (Code of Federal Regulations) regulates food and medications in the United States. Part 11 of this act establishes guidelines for the Food and Drug Administration-regulated enterprises’ use of information systems. By adhering to the guidelines outlined in this document, you can rest assured that your data will be secure and traceable.

Controls that restrict system and data access to only those with authentic credentials (electronic signatures).
Regularly required password modifications
Audit traces, which are chronological logs of all database activity and alterations, provide assurance regarding the integrity of a database.

All of these precautions are taken to ensure that the system’s output is accurate.

2. eCRF specialist

This component provides a library of pre-designed eCRF layouts, data entry fields, and a drag-and-drop user interface for simple customization. The filled-out forms may be saved and utilized in subsequent endeavors. In the designer, the editor also supports programmable edit tests.

3. Query clinical data management

During clinical trials, sponsors may send researchers queries requesting additional data. These requests are issued during the examination of the data, prior to securing the database, to correct any discrepancies or errors discovered. The query administration function facilitates communication between data managers, sponsors, and other parties with an interest.

4. Monitoring

The monitoring system’s capabilities include the ability to schedule alerts at predetermined intervals, document undesirable events, and send alerts directly to the sponsors.

5. Medical coding support

This module streamlines the processes of code search, system cross-coding mapping, and error checking.

6. Bringing in and sending out data

Some systems simplify the process of combining data from multiple locations. The data export function converts trial database data into formats preferred by analysts and mandated by research sponsors and regulatory agencies.

What are the clinical data management tools?
1. IBM clinical progress instrument

IBM Clinical Development (ICD) is a comprehensive cloud-based system designed for decentralized, large-scale studies that can aggregate data from multiple sources. As it generates analytical reports, the trial data management cycle is only the beginning of its capabilities.

ICD is advantageous due to its dependability, extensive library of pre-built forms, user-friendliness, and adaptable, modular design. Select and pay only for the functionalities you utilize. The medical coding procedure is assisted by IBM Watson’s AI prowess.

It is essential to keep in mind that a programmer must initiate a test. Users have also noted the system’s exorbitant ownership cost, which makes it unsustainable for new businesses, along with its antiquated user interface and sluggish customer support.

2. Oracle’s clinical research application is ideally suited for assisting with historical research.

A CDMS on the market has existed for some time and consists of three distinct but complementary systems. Among these systems are:

Oracle Clinical’s automated trial protocol formulation, data validation, and report generation.
Oracle Remote Data Capture is an Electronic Data Capture system that includes a layout editor to facilitate the creation of collection forms.
Integration of medical terminologies via a centralized Thesaurus Management System.

The suite, which is based on the Oracle database, is highly stable and widely regarded as one of the most efficient manual data collection techniques. Data entry is an essential but challenging and time-consuming process. Oracle is not designed for start-up companies with limited resources.

3. Castor EDC: a cost-effective method for speeding up prototype construction

Castor EDC’s capacity to significantly reduce clinical trial construction time led to its rapid adoption in more than 90 nations. The system’s intuitive interface simplifies the creation of electronic case report forms (eCRF), the assignment of study responsibilities, and the addition of new users. Electronic health record (EHR) systems, medical devices, and wearables can all contribute data, which can be linked seamlessly.

In the event of an emergency, you can expect assistance within thirty minutes from a qualified professional. The platform’s inexpensive price makes its use feasible for startups. It has limited functionality and export options in comparison to more extensive and expensive alternatives.

Device TrialKit

TrialKit is a mobile and web-based application for virtual, decentralized research. With a collection of pre-made templates and a drag-and-drop CRF builder, businesses can create eCRFs without the need for coding knowledge, allowing them to begin trials in days as opposed to weeks. The software can easily incorporate data from wearable devices like Fitbit and Apple Watch, as well as electronic health records.

The platform’s steep learning curve, which could be a hindrance, is one of the obstacles affecting clinical data management with this tool. Poor functionality is an additional prevalent disadvantage.

Guidelines and regulatory requirements for clinical data management

We’ve included some guidelines below to assist you in selecting and implementing a CDMS to help your trial succeed.

Evaluate your alternatives for compatibility and integration

Verify that your selected CDMS integrates well with the other platforms you intend to use during the trial, such as an EHR system, a laboratory information management system (LIMS), and others. To resolve compatibility issues, it is essential to find a technical collaborator skilled in system integration.

Acquire additional information regarding the quality of a company’s product support

Included in this category are the speed with which problems are resolved and the quality of user training. Confirm that the service provider will assist you with system implementation, integrations, and the creation of new features if needed.

Ensure satisfaction among all stakeholders.

Before executing a platform, the research site should solicit feedback from CROs, sponsors, employees, and technical support. Utilize a free trial or demo version so that everyone can test the user interface and provide feedback.

Concentrate on your tool’s fundamental functionalities

Extraneous functions raise costs and make life more difficult for employees who must master a new system. As your project evolves and develops, you can add new modules from the same vendor, integrate third-party technologies, or add custom programming.

Compare the chosen instrument to the eCRF and verify its accuracy

After developing electronic forms, it is necessary to conduct user acceptability testing. It is crucial for end users, such as data entry specialists, clinicians, and researchers, to evaluate the eCRF structure and ensure that it contains all pertinent variables.

· Prepare a database thoroughly

The sponsors of the trial desire that the system be operational as soon as feasible. Efficiency and security must coexist in harmony. Take time to design and evaluate the database prior to the investigation. Costly and potentially invalidating software updates throughout the duration of the experiment could compromise the results.

Final remark

In this article, our professional writers provide unparalleled quality cheat sheets on how to write a clinical data management plan. They deserve a token of our appreciation. Follow the steps and procedures outlined in this article to enhance your skills as a healthcare professional. We can assist you in completing your clinical data management essay at customnursingpapers.com.

Today, take advantage of our services to become the top student in your class. Collaborating with our experts will allow you to become the finest healthcare practitioner at your institution.

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How to develop a clinical data management strategy

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