GoConqr has a new look! Let us know what you think.

Sign up free

Flashcards

Data Management and Project Management

A M Clinical Research Topics Professional English 41 cards

Cards in this deck (41)

  1. 1What is clinical data management?Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. Clinical Data Management assures collection, integration and availability of data at appropriate quality and cost. Clinical Data Management supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). The ultimate goal of CRDM is to assure that data support conclusions drawn from research. Achieving this goal protects public health and confidence in marketed therapeutics.
  2. 2What is the role of the Clinical Data Manager in a Clinical Trial?The clinical data manager is involved in early discussions about data collection options and then oversees development of data collection tools based on the clinical trial protocol.
    Once subject enrollment begins, the data manager ensures that data is collected, validated, complete and consistent.
    The clinical data manager liaises with other data providers (e.g. a central laboratory processing blood samples collected) and ensures that such data are transmitted securely and is consistent with other data collected in the clinical trial.
    At the completion of the clinical trial, the clinical data manager ensures that all data expected to be captured has been accounted for and that all data management activities are complete. At this stage, the data is declared final (terminology varies but common descriptions are Database Lock and Database Freeze) and the clinical data manager transfers data for statistical analysis.
  3. 3Define Standard Operating Procedures in the context of Data Management in Clinical TrialsStandard Operating Procedures (SOPs) describe the process to be followed in conducting data management activities and support the obligation to follow applicable laws and guidelines (e.g. ICH GCP and 21CFR Part 11) in the conduct of data management activities.
  4. 4What is a data management plan?The data management plan describes the activities to be conducted in the course of processing data.
    Key topics to cover include the SOPs to be followed, clinical data management system to be used, description of data sources, data handling processes, data transfer formats and process, and quality control procedures to be applied.
  5. 5Explain edit check programmingEdit checks are used to fire a query message when discrepant data is entered, to map certain data points from one CRF to the other, to calculate certain fields like Subject's Age, BMI etc..
  6. 6How are edit checks helpful?Edit checks help the investigators to enter the right data right at the moment data is entered and also help in increasing the quality of the Clinical trial data.
  7. 7What is computer system validation?All computer systems used in the processing and management of clinical trial data must undergo validation testing to ensure that they perform as intended and that results are reproducible.
  8. 8CDISCClinical Data Interchange Standards Consortium
  9. 9What does CDISC do?The Clinical Data Interchange Standards Consortium leads the development of global, system independent data standards which are now commonly used as the underlying data structures for clinical trial data. These describe parameters such as the name, length and format of each data field (variable) in the relational database.
  10. 10What are validation rules?Validation Rules are electronic checks defined in advance which ensure the completeness and consistency of the clinical trial data.
  11. 11What is data validation?Data validation is the application of validation rules to the data. For electronic CRFs the validation rules may be applied in real time at the point of entry. Offline validation may still be required (e.g. for cross checks between data types)
  12. 12what is a ‘query’?A query is an error generated when a validation check detects a problem with the data. Validation checks are run automatically whenever a page is saved “submitted” and can identify problems with a single variable, between two or more variables on the same eCRF page, or between variables on different pages.
  13. 13Can a variable have multiple validation checks associated with it?Yes
  14. 14How are queries/errors generally resolved?Errors can be resolved in several ways:
    ■by correcting the error – entering a new value for example or when the datapoint is updated
    ■by marking the variable as correct – some EDC systems required additional response or you can raise a further query if you are not satisfied with the response
  15. 15How is lab data generated during a clinical trial managed?Samples collected during a clinical trial may be sent to a single central laboratory for analysis. The clinical data manager liaises with the central laboratory and agrees data formats and transfer schedules. The sample collection date and time may be reconciled against the CRF to ensure that all samples collected have been analysed.
    Analysis of clinical trial data may be carried out by laboratories, image processing specialists or other third parties. The clinical data manager liaises with such data providers and agree data formats and transfer schedules. Data may be reconciled against the CRF to ensure consistency.
  16. 16Serious adverse event reconciliation and data managementThe CRF collects Adverse Events reported during the conduct of the clinical trial however there is a separate process which ensures that Serious Adverse Events are reported quickly. The clinical data manager must ensure that data is reconciled between these processes.
  17. 17What are patient recorded data and how are they handled by data management teams?Where the subject is required to record data (e.g. daily symptoms) then a diary is provided for completion. Data management of this data requires a different approach to CRF data as, for example, it is generally not practical to raise data queries. Patient diaries may be developed in either paper or electronic (eDiary) formats. Such eDiaries generally take the form of a handheld device which enables the subject to enter the required data and transmits this data to a centralised server.
  18. 18When is the database finalized?Once all expected data are accounted for, all data queries closed, all external data received and reconciled and all other data management activities complete the database may be finalized.
  19. 19Typical reports generated and used by the clinical data manager includes:Status of page completion / missing pages
    Status of data queries
    Data queries not resolved within specified time limit
    Commonly raised data queries (to help identify areas where improvements can be made)
  20. 20Axiom’s DM approach is designed to ensure that the resulting data isaccurate, scientifically credible, and was thoroughly reviewed against the protocol, GCP and therapeutic requirements.
  21. 21What questions may be asked by the project team during systems validation?What are the specific functions required by the project, and how will these be developed and tested in the context of the study team?
    Does the EDC system require software to be loaded onto user computers, and what is the proper installation and testing of the installation?
    How will the system be maintained, with proper management and coordination of changes to minimize disruptions to the project?
    What are the plans to provide backup systems or processes should the system fail?
    In the parlance of information technology and quality assurance, these key points are referred to as validation plan or protocol, installation qualifications, operational qualifications, performance qualifications, contingency or disaster recovery plan, and change control.
  22. 22SOPs should be established for, but not limited to, the following processes: (combine with other slide)System setup and installation
    Data collection and handling
    System maintenance
    Data backup, recovery, and contingency plans
    Security
    Change control
  23. 23Why is it critical for the project management to involve the lead monitors during the review of the edit checks?since the edit checks will become transparent to the end users as data are captured and monitored.
  24. 24UAT typically occurs on two levels.One level tests the systems to determine if all the functions as stated in the functional requirements have been met. The second level tests the system to ensure the eCRF design and flow adheres to the study protocol specifications.
  25. 25What questions must be asked before UAT begins?Which team members are responsible for testing and final approval of UAT?
    What is the estimated timeline for UAT (before and after study roll-out)?
    How will changes be documented and tracked?
    How will investigator sites be notified of changes made during UAT, if the system has already been deployed?
  26. 26EDC tool security can be broken down into two categories:Typically, security can be broken down into two categories: physical and logical. According to the FDA, physical security measures include such barriers as locks, in addition to external safeguards that ensure that access to the computerized system and to the data is restricted to authorized personnel.
    Logical security includes the use of passwords or recognition devices that limit access to the computer functions according to job responsibilities. In practice, the user ID and password security process is only as good as the security of these access codes. It is therefore extremely important to train and remind the users of the importance of keeping these codes confidential.
  27. 27Security is a vital element to any EDC tool from botha regulatory and legal perspective.
  28. 28A computerized audit trail is defined clearly asAn electronically generated record that allows reconstruction of the course of events relating to the creation, modification, and deletion of an electronic record. Section 21 CFR 11.10(e) goes further to explain that a computerized audit trail is also designed to protect the authenticity, integrity, and when appropriate, the confidentiality of electronic records.
  29. 29The following security questions must be answered during the planning stages of the EDC project:How will your sites be trained on system security?
    What measures (such as unique user IDs and passwords) is your EDC system or project team taking to limit the access to authorized personnel only ?
    How are your security measures updated, and how often?
    If software used for a clinical study is added to a system normally used for other purposes, what efforts should be made to ensure the study software is logically and physically separated to preclude unintended interaction with non-study software?
    Does an SOP exist for handling and storing the system to prevent unauthorized access?
  30. 30Project management must be aware of the vendor’s help desk capabilities and proactively work to define the vendor’s responsibilities. Explain.Poor planning at this stage often results in unclear definitions as to who is supposed to do what. For example, study personnel may not know whether to call the study monitor or the software vendor’s help desk when they have a software problem.
  31. 31When preparing for the discussions regarding EDC helpdesk support, the project management team must define the difference betweenSoftware support,
    Hardware support, and
    Clinical monitoring support.
  32. 32Most sponsors want clinical monitoring questions to come to them or their contract research organization, but what happens when clinical questions that involve the use of the software arrive at the vendor help desk, or vice versa?To overcome some of these obstacles, the project management team should early on identify a point person from the project team who will be responsible for all EDC-related issues as they relate to the use of the system. It does not take long for someone to learn the system nuances and then be able to troubleshoot common problems or questions, which will save time and money compared with having the users call a software help desk.
  33. 33Helpdesk: Identify answers to the following questions to clarify responsibility for user support:Who is responsible for writing the service level agreement between all parties?
    To what extent have you trained your monitors and staff to anticipate and address problems related to the use of the system?
    How are calls escalated through the various levels from protocol issues to hardware issues to EDC core software functionality?
    Who is responsible for maintaining the hardware service contracts for computers that might be purchased for the study
  34. 34EDC tracking metrics: What are some of the issues to address?What groups (for example, clinical, data management, and quality assurance) need to be involved in the development of EDC tracking metrics?
    How does your project management team plan to respond to the metrics?
    How quickly can your EDC tool track metrics, and in what format are they collected, reviewed, and accessed?
  35. 35During the start-up phase, it is wise to start outlining your project team’s requirement for data.... (3 main requirements)backup,
    recovery, and
    archival
  36. 36Most companies already have traditional paper-based records retention requirements pretty well defined, but some are now finding that the introduction of computerized systems for data capture and storage have added an entirely new set of logistical concerns. Explain 2 such scenarios.For example, who is required to archive study data after study completion if both the site and a central repository collect, store, and archive data during the course of the study?
    Should a sponsor require sites to archive the study hardware because it has the physical operating system designed to review the data, in case FDA audits the site?
  37. 37In addition to addressing issues regarding backup, recovery, and archival, the project management team should define a contingency plan that includes some, if not all, of the following:General problems (for example, users who are unable to log on, actions that result in error messages, or system lockups)
    Telecommunication or transmission problems (for example, users who cannot connect via the preferred method of transmission, or monitors who cannot view or download data to review)
    Corrupted local systems or corrupted data on the study computer (for example, users who cannot enter, delete, or change data)
    Problems requiring significant time to resolve (for example, damaged hardware, or the inability to perform backup of the study data).
  38. 38Additional questions: During planning, the team should answer these questions (in reference to EDC tools):Do you have a contingency plan for continuing the study by alternative means in the event of failure of the computerized system?
    Is there an SOP for backup and recovery procedures that is sufficient to protect against data loss?
    How will study data be archived at the investigator site once the trial has been completed?
    In case of an audit, how will the FDA be able to review the clinical data?
    Can you ensure an auditor will have access to the audit trail with the method of archival you have selected?
  39. 39Data management QCSince an average error rate for keying text or numbers is about 1 per 300 keystrokes, the entered data is QC'd by having an independent data entry person enter the same data.
    Both sets of data are compared electronically, and discrepancies are resolved by a senior data entry person. After all of the data has been entered and all discrepancies and questions resolved, the database is QC'd by comparing the database to the CRFs from which the data was entered.
  40. 40Data management QAData entry and the database QC process are other critical areas of the data management process that are audited by QA personnel. The audits review the documented evidence that shows the data accuracy and integrity were verified and checked manually, independently, and programmatically to ensure the data were logical. These audits also ensure that all data queries are resolved and that the overall database QC review was conducted according to the QC SOP.
  41. 41Examples of data management metrics for QA are:percentage of database errors
    percentage of queries manually generated
    time from last patient out to database lock
    number of times a locked database is opened

Information

Description
Professional Clinical Research Topics (Clinical Research) Flashcards on Data Management and Project Management, created by A M on 25/02/2016.
Created by
A M
Views
9
Rating

Feedback

What is it about?

What do you think of the new look?

How do you like it?