This glossary will help you understand words and phrases frequently used on ClinicalTrials. Many of these words are also used by clinical researchers and others in the same or a similar manner. But the definitions below are provided to explain content on ClinicalTrials. For more information, see Participating in Studies on this site. A patient registry is a type of observational study. Note: The ClinicalTrials.
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The draft contains numerous revisions that address changes in the scale, complexity, and cost of clinical trials since the previous version was adopted. Since clinical researchers have access to new technology and risk management processes that may increase efficiency and focus on relevant clinical trial activities, E6 is being amended to encourage the implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting, while ensuring that human subject protection and data integrity are maintained.
In addition, the update includes changes to clarify standards on electronic records and essential documents. Ultimately, the new document is designed to help clinical researchers protect human subjects, maintain data quality and integrity, and properly document trial results.
This article will highlight the key changes that affect research practitioners. These revisions are expected to be reviewed and accepted within ICH and then incorporated into the E6 document by the end of Section 1 Glossary includes the addition of new definitions or enhancements to existing definitions.
One key enhancement is found in the definition in a certified copy of a case report form 1. The definition of monitoring 1. In addition, the monitoring report 1. The expanded definition will ensure that sponsors create a report to show the centralized monitoring that was performed. The definition of unexpected adverse drug reaction 1. Validation should ensure accuracy, reliability, and consistent intended performance, from design until decommissioning of the system or transition to a new system.
In section 2. Several additions are proposed to the Investigator section section 4. In Adequate Resources section 4. First, section 4. In section 4. Source data should be attributable, legible, contemporaneous, original, accurate, and complete. Changes to source data should be traceable, should not obscure the original entry, and should be explained if necessary e. Section 5, Sponsors, contains substantial changes and additions.
The draft includes a major new section 5. Although risk management processes are well known in the medical products industry, they have not been widely applied to the planning and implementation of clinical trials.
The update will require clinical trials sponsors to begin acquiring the necessary training and resources to establish these principles.
Two helpful general resources are ICH Q9, Quality Risk Management, which is a high-level overview of risk management principles, and ISO , Application of Risk Management to Medical Devices, a global safety standard applicable to all stages in the life cycle of a medical device, including its early development. While both these documents are tailored toward manufacturing risk management, they may present useful information applicable to clinical trial planning, as well.
Table 1 lists the full text of the proposed quality management section. Section 5. The revisions state that sponsors may not abdicate this responsibility and must take a more active role in their oversight of their CROs.
The SOPs should describe system validation and functionality testing, data collection and handling, system maintenance, system security measures, change control, data backup, recovery, contingency planning, and decommissioning. The responsibilities of the sponsor, investigator, and other parties with respect to the use of these computerized systems should be clear, and the users should be provided with training in the use of the systems.
Revisions to the section on monitoring 5. These revisions are noted in section 5. The flexibility in the extent and nature of monitoring described in this section is intended to permit varied approaches that improve the effectiveness and efficiency of monitoring. A combination of on-site and centralized monitoring activities may be appropriate.
The sponsor should document the rationale for the chosen monitoring strategy e. Examples provided are:. Results of monitoring activities should be documented in sufficient detail to allow verification of compliance with the monitoring plan. The draft also proposed a new section 5. The plan should describe the monitoring strategy, the monitoring responsibilities of all the parties involved, the various monitoring methods to be used, and the rationale for their use.
The plan should also emphasize the monitoring of critical data and processes. Particular attention should be given to those aspects that are not routine clinical practice and that require additional training.
The monitoring plan should reference the applicable policies and procedures. The new section 5. If required by applicable law or regulation, the sponsor should inform the regulatory authority ies when the noncompliance is a serious breach of the trial protocol or GCP.
The last revision adds to section 8. The storage system irrespective of the media used should provide for document identification, search, and retrieval. Depending on the activities being carried out, individual trials may require additional documents not specifically mentioned in the essential document list. The sponsor should ensure that the investigator has control of and continuous access to the CRF data reported to the sponsor. The sponsor should not have exclusive control of those data.
Use of statistical analyses to identify data trends such as the range and consistency of data within and across sites. Analysis of site characteristics and performance metrics. Regenerative Medicine: Steps to Accelerate Development. Ask the Experts: Informed Consent Requirements.
Update of E6: The ICH GCP Guideline
Glossary of Common Site Terms