Clinical Data Interchange Standards Consortium (CDISC)
August 22, 2024
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A Case Report Forms (CRF) is a document crafted to capture every bit of patient information needed by the sponsor during clinical research. Its development plays a big role in a clinical trial and has an impact on the final outcome of the study. Designing a case report form requires extensive planning and meticulous dedication to detail. It is essential to correctly analyze the safety and efficacy of the medicinal product during a clinical trial by building a CRF. The CRF should be created to gather data as efficiently as possible while adhering to regulatory standards, the study protocol, and the researcher’s need to test hypotheses or respond to trial-related queries.
The key components of the study protocol (such as protocol number, protocol title, participant selection criteria, assessments, and visits) should be represented in a well-designed CRF, which is best created after the study protocol has been completed. It can be produced simultaneously with the development of the protocol. But this might lead to multiple versions; hence, version control must be maintained. Given that all strategies have drawbacks as well as benefits, the timing of the design stage will be crucial.1
The quality and integrity of the data obtained are what CRFs are primarily responsible for protecting and maintaining. Due to the fact that they include all patient-related information, CRFs are crucial to any clinical research project. To minimize future hassles with safety issues, cross-checks, regulatory inspections, etc. Clinical researchers are realizing the increasing importance of a well-designed CRF. It is important to note that a poor CRF design might result in gathering incorrect, excessive, or insufficient data, which understates the importance of a good CRF. Understanding what should make up a CRF is crucial because the CRF’s significance is centered on data collection.
An approach for a task that is well-known to an organization allows them to feel more secure. While switching to a cloud-based system, significant change is involved, and organizations view this change as a source of risk and uncertainty. Additionally, there are several myths about converting to a cloud-based system that discourage businesses from making the shift.
A cloud-based system can hold an electronic CRF (eCRF), which is the traditional CRF in electronic format.2 Despite the fact that cloud-based Electronic Data Capture (EDC) techniques for eCRFs have been operational for more than 15 years, between 25 and 50% of new clinical studies are projected to still use paper. According to a poll of biopharma industry executives, the most significant barriers to using an EDC system are the startup cost and security concerns. Additionally, respondents mentioned the small size of their clinical trial and the additional staff training needed as reasons why they would not choose an EDC system.3 There is a critical need to lower the cost of clinical trials as the regulatory requirements tighten and drug development prices rise. However, it is thought that these barriers are actually myths.
Below are some of the myths related to paper-based CRFs that have led some organizations to still use traditional CRFs rather than going all digital:
Myth: Traditional CRFs don’t require a monthly licensing charge and have a cheap start-up expense. To effectively utilize eCRFs and move to cloud-based solutions, extensive training is required.
However, as more time requires more money, utilizing written documents or spreadsheets for longer actually results in higher expenditures. Traditional CRFs must be manually built each time, which requires more time. The annotated CRFs, which must be created from scratch for each form and research, are another issue. Additionally, because formats cannot be enforced and the information collected must be entered manually into a computer, traditional CRFs are more likely to include data mistakes. Typically, traditional CRFs are only financially viable for small businesses doing modest research.
Myth: Data security is ensured by using a secure central location, such as a vault.
Written documents are more prone to errors and can have their content compromised or accidentally modified by users. It might be challenging to find the most recent CRF that has been approved by all the stakeholders. EDCs, on the other hand, utilize encryption alongside off-site encrypted backups to protect data while it is in transit and while being stored. All the data-related activities are completed prior to the final database lock. Following locking, the data in the CRF cannot be modified in any way.
Myth: Although it is believed that the method of data collection has little impact on the duration of clinical trials, this is not the case.
It has been demonstrated that employing an EDC helps speed up trial duration. According to a study, the time taken for trial planning and database lock from EDC can be shortened by 27–41% and 41–65%, respectively.
The transition to adopting eCRFs and EDCs necessitates extensive software training
Myth: Training is considered to take up a significant amount of time. It is challenging since there are already strict timelines for clinical trials. Making spreadsheets or written documents does not require any special software knowledge.
Less training is needed than one might think. It is very time-efficient to use a cloud-based solution that automates the creation of eCRFs. Although some initial training is needed, the time saved in the long run makes it significantly more effective.
As previously stated, CRFs in clinical trials must adhere to regulatory agency regulations. The CRFs are subject to the Clinical Data Interchange Standards Consortium’s (CDISC) format. The CDISC Operational Data Model (ODM), an open Extensible Markup Language (XML)-based transport standard, can represent individual patient data elements. By the end of 2016, the U.S. Food and Drug Administration (FDA) announced that Define XML (using CDISC ODM) would become mandatory for new drug applications.4 Additionally, the Clinical Data Acquisition Standards Harmonization (CDASH) Model offers guidelines for creating CRFs that include certain generally applicable variables.5
The following are some considerations that might help in CRF design:
Standardizing CRFs is crucial to meeting the demands of all stakeholders, including investigators, biostatisticians, data managers, data entry staff, etc. CRFs must be easy to use and collect reliable, valid, and consistent data. You can reuse CRFs by standardizing them. That represents a significant improvement in efficiency. They will be consistent and of exceptional quality because they have previously been checked and approved. Additionally, not every form needs to have an annotation made manually. Moreover, you may reuse edit checks that often require a lot of time and resources. Therefore, it saves a ton of time and resources and is also a lot less headache.
The CRFs are frequently reviewed by the study monitor (CRA) or central data coordinator for readability, completeness, and accuracy. The research coordinator or monitor will need to fix any inaccuracies or missing data that they find. Before the data may be passed on to the Contract Research Organization (CRO) or Sponsor for some studies, this will need to be completed. Other studies could make use of data verifiers, which examine all data fields and produce queries that are sent to the study center seeking changes to the main study document and electronic changes in the database. An explanation in the form of a memo or note to file may be necessary in the case of missing data, data discrepancies, or deviations from the study protocol.6
This blog concludes that in order to speed up the manufacturing of new interventions, regulatory submissions, and post-marketing studies, CRFs support the effective, scientifically reliable generation and reporting of clinical data. It also makes sharing of data, comparison, and collection possible for high-quality, novel study outcomes to fill knowledge gaps. Additionally, this blog offers evidence that using an eCRF results in a significant time savings for entering self-reported patient data and data obtained by research staff into an EDC system. In terms of time efficiency, quality of data, and patient utilization, the use of eCRFs in clinical study settings should be encouraged over the use of traditional CRFs.
A case report forms (CRF) are a document crafted to capture every bit of patient information needed by the sponsor during clinical research. It collects data on baseline characteristics, primary and secondary outcome measures, and adverse events during or after each visit.
Case report forms are used to record the critical information of participants in a formal and confidential manner. The CRFs should be created to gather data as efficiently as possible while adhering to regulatory standards. The study protocol, and researcher’s need to test hypotheses or respond to trial-related queries.
Yes, Case Report Forms (CRFs) are used in clinical trials to collect data on the safety and efficacy of investigational drugs. However, they can also be used in other medical studies and research projects where systematic data collection is required. Additionally, CRFs can be used in clinical practice to document patients’ medical history, symptoms, and treatment plans.
A Clinical Research Coordinator (CRC) is responsible for completing the participant’s CRF. When all the entries are done and it is deemed to be complete. It is signed by the principal investigator to assert that it is complete and correct. In some cases, physicians, nurses, or other designated study staff are also responsible for collecting and documenting the required data in a timely manner.
Yes, eCRFs can replace paper-based CRFs. eCRFs offer advantages such as faster data collection, real-time data accessibility, and improved data quality. Making them a more efficient and effective alternative to paper-based forms. They also reduce the need for manual data entry and transcription, which can decrease the risk of errors and save time.
CRFs offer a standardized method for recording information about adverse events. Including severity, treatment given, and outcome, helping investigators and sponsors to evaluate the safety profile of investigational products. The CRFs are then reviewed by the relevant study personnel and the sponsor or CRO to determine if the adverse event meets the regulatory definition of a reportable event.
A Case Report Forms (CRF) is a document crafted to capture every bit of patient information needed by the sponsor during clinical research. Its development plays a big role in a clinical trial and has an impact on the final outcome of the study. Designing a case report form requires extensive planning and meticulous dedication to detail. It is essential to correctly analyze the safety and efficacy of the medicinal product during a clinical trial by building a CRF. The CRF should be created to gather data as efficiently as possible while adhering to regulatory standards, the study protocol, and the researcher’s need to test hypotheses or respond to trial-related queries.
The key components of the study protocol (such as protocol number, protocol title, participant selection criteria, assessments, and visits) should be represented in a well-designed CRF, which is best created after the study protocol has been completed. It can be produced simultaneously with the development of the protocol. But this might lead to multiple versions; hence, version control must be maintained. Given that all strategies have drawbacks as well as benefits, the timing of the design stage will be crucial.1
The quality and integrity of the data obtained are what CRFs are primarily responsible for protecting and maintaining. Due to the fact that they include all patient-related information, CRFs are crucial to any clinical research project. To minimize future hassles with safety issues, cross-checks, regulatory inspections, etc. Clinical researchers are realizing the increasing importance of a well-designed CRF. It is important to note that a poor CRF design might result in gathering incorrect, excessive, or insufficient data, which understates the importance of a good CRF. Understanding what should make up a CRF is crucial because the CRF’s significance is centered on data collection.
An approach for a task that is well-known to an organization allows them to feel more secure. While switching to a cloud-based system, significant change is involved, and organizations view this change as a source of risk and uncertainty. Additionally, there are several myths about converting to a cloud-based system that discourage businesses from making the shift.
A cloud-based system can hold an electronic CRF (eCRF), which is the traditional CRF in electronic format.2 Despite the fact that cloud-based Electronic Data Capture (EDC) techniques for eCRFs have been operational for more than 15 years, between 25 and 50% of new clinical studies are projected to still use paper. According to a poll of biopharma industry executives, the most significant barriers to using an EDC system are the startup cost and security concerns. Additionally, respondents mentioned the small size of their clinical trial and the additional staff training needed as reasons why they would not choose an EDC system.3 There is a critical need to lower the cost of clinical trials as the regulatory requirements tighten and drug development prices rise. However, it is thought that these barriers are actually myths.
Below are some of the myths related to paper-based CRFs that have led some organizations to still use traditional CRFs rather than going all digital:
Myth: Traditional CRFs don’t require a monthly licensing charge and have a cheap start-up expense. To effectively utilize eCRFs and move to cloud-based solutions, extensive training is required.
However, as more time requires more money, utilizing written documents or spreadsheets for longer actually results in higher expenditures. Traditional CRFs must be manually built each time, which requires more time. The annotated CRFs, which must be created from scratch for each form and research, are another issue. Additionally, because formats cannot be enforced and the information collected must be entered manually into a computer, traditional CRFs are more likely to include data mistakes. Typically, traditional CRFs are only financially viable for small businesses doing modest research.
Myth: Data security is ensured by using a secure central location, such as a vault.
Written documents are more prone to errors and can have their content compromised or accidentally modified by users. It might be challenging to find the most recent CRF that has been approved by all the stakeholders. EDCs, on the other hand, utilize encryption alongside off-site encrypted backups to protect data while it is in transit and while being stored. All the data-related activities are completed prior to the final database lock. Following locking, the data in the CRF cannot be modified in any way.
Myth: Although it is believed that the method of data collection has little impact on the duration of clinical trials, this is not the case.
It has been demonstrated that employing an EDC helps speed up trial duration. According to a study, the time taken for trial planning and database lock from EDC can be shortened by 27–41% and 41–65%, respectively.
The transition to adopting eCRFs and EDCs necessitates extensive software training
Myth: Training is considered to take up a significant amount of time. It is challenging since there are already strict timelines for clinical trials. Making spreadsheets or written documents does not require any special software knowledge.
Less training is needed than one might think. It is very time-efficient to use a cloud-based solution that automates the creation of eCRFs. Although some initial training is needed, the time saved in the long run makes it significantly more effective.
As previously stated, CRFs in clinical trials must adhere to regulatory agency regulations. The CRFs are subject to the Clinical Data Interchange Standards Consortium’s (CDISC) format. The CDISC Operational Data Model (ODM), an open Extensible Markup Language (XML)-based transport standard, can represent individual patient data elements. By the end of 2016, the U.S. Food and Drug Administration (FDA) announced that Define XML (using CDISC ODM) would become mandatory for new drug applications.4 Additionally, the Clinical Data Acquisition Standards Harmonization (CDASH) Model offers guidelines for creating CRFs that include certain generally applicable variables.5
The following are some considerations that might help in CRF design:
Standardizing CRFs is crucial to meeting the demands of all stakeholders, including investigators, biostatisticians, data managers, data entry staff, etc. CRFs must be easy to use and collect reliable, valid, and consistent data. You can reuse CRFs by standardizing them. That represents a significant improvement in efficiency. They will be consistent and of exceptional quality because they have previously been checked and approved. Additionally, not every form needs to have an annotation made manually. Moreover, you may reuse edit checks that often require a lot of time and resources. Therefore, it saves a ton of time and resources and is also a lot less headache.
The CRFs are frequently reviewed by the study monitor (CRA) or central data coordinator for readability, completeness, and accuracy. The research coordinator or monitor will need to fix any inaccuracies or missing data that they find. Before the data may be passed on to the Contract Research Organization (CRO) or Sponsor for some studies, this will need to be completed. Other studies could make use of data verifiers, which examine all data fields and produce queries that are sent to the study center seeking changes to the main study document and electronic changes in the database. An explanation in the form of a memo or note to file may be necessary in the case of missing data, data discrepancies, or deviations from the study protocol.6
This blog concludes that in order to speed up the manufacturing of new interventions, regulatory submissions, and post-marketing studies, CRFs support the effective, scientifically reliable generation and reporting of clinical data. It also makes sharing of data, comparison, and collection possible for high-quality, novel study outcomes to fill knowledge gaps. Additionally, this blog offers evidence that using an eCRF results in a significant time savings for entering self-reported patient data and data obtained by research staff into an EDC system. In terms of time efficiency, quality of data, and patient utilization, the use of eCRFs in clinical study settings should be encouraged over the use of traditional CRFs.
A case report forms (CRF) are a document crafted to capture every bit of patient information needed by the sponsor during clinical research. It collects data on baseline characteristics, primary and secondary outcome measures, and adverse events during or after each visit.
Case report forms are used to record the critical information of participants in a formal and confidential manner. The CRFs should be created to gather data as efficiently as possible while adhering to regulatory standards. The study protocol, and researcher’s need to test hypotheses or respond to trial-related queries.
Yes, Case Report Forms (CRFs) are used in clinical trials to collect data on the safety and efficacy of investigational drugs. However, they can also be used in other medical studies and research projects where systematic data collection is required. Additionally, CRFs can be used in clinical practice to document patients’ medical history, symptoms, and treatment plans.
A Clinical Research Coordinator (CRC) is responsible for completing the participant’s CRF. When all the entries are done and it is deemed to be complete. It is signed by the principal investigator to assert that it is complete and correct. In some cases, physicians, nurses, or other designated study staff are also responsible for collecting and documenting the required data in a timely manner.
Yes, eCRFs can replace paper-based CRFs. eCRFs offer advantages such as faster data collection, real-time data accessibility, and improved data quality. Making them a more efficient and effective alternative to paper-based forms. They also reduce the need for manual data entry and transcription, which can decrease the risk of errors and save time.
CRFs offer a standardized method for recording information about adverse events. Including severity, treatment given, and outcome, helping investigators and sponsors to evaluate the safety profile of investigational products. The CRFs are then reviewed by the relevant study personnel and the sponsor or CRO to determine if the adverse event meets the regulatory definition of a reportable event.
Supporting Healthcare and Pharmaceutical Industries Across Internal, External, and Regulatory Communications. Delivering Top-Tier Support for Our Client’s Success.
Supporting Healthcare and Pharmaceutical Industries Across Internal, External, and Regulatory Communications. Delivering Top-Tier Support for Our Client’s Success.