Difference between revisions of "About-cancer/treatment/clinical-trials/what-are-trials/team"
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| − | == Research Team Members == | + | == Research Team Members == <!--T:1--> |
| + | <!--T:2--> | ||
Designing and running a clinical trial requires the skills of many different types of experts. Each team may be set up differently at different sites. Typical team members and their responsibilities include: | Designing and running a clinical trial requires the skills of many different types of experts. Each team may be set up differently at different sites. Typical team members and their responsibilities include: | ||
| + | <!--T:3--> | ||
'''Principal investigator''' – supervises all aspects of a clinical trial. This person: | '''Principal investigator''' – supervises all aspects of a clinical trial. This person: | ||
| + | <!--T:4--> | ||
:*Develops the concept for the trial | :*Develops the concept for the trial | ||
| + | <!--T:5--> | ||
:*Writes the protocol | :*Writes the protocol | ||
| + | <!--T:6--> | ||
:*Submits the protocol for the Institutional Review Board (IRB) approval | :*Submits the protocol for the Institutional Review Board (IRB) approval | ||
| + | <!--T:7--> | ||
:*Directs the recruitment of patients | :*Directs the recruitment of patients | ||
| + | <!--T:8--> | ||
:*Manages the informed consent process | :*Manages the informed consent process | ||
| + | <!--T:9--> | ||
:*Supervises data collection, analysis, interpretation, and presentation | :*Supervises data collection, analysis, interpretation, and presentation | ||
| + | <!--T:10--> | ||
'''Research nurse''' – manages the collection of data throughout the course of a clinical trial. This person: | '''Research nurse''' – manages the collection of data throughout the course of a clinical trial. This person: | ||
| + | <!--T:11--> | ||
:*Educates staff, patients, and referring health care providers about the trial | :*Educates staff, patients, and referring health care providers about the trial | ||
| + | <!--T:12--> | ||
:*Communicates regularly with the principal investigator | :*Communicates regularly with the principal investigator | ||
| + | <!--T:13--> | ||
:*Assists the principal investigator with the informed consent process, study monitoring, quality assurance, audits, and data management and analysis | :*Assists the principal investigator with the informed consent process, study monitoring, quality assurance, audits, and data management and analysis | ||
| + | <!--T:14--> | ||
'''Data manager''' – manages the collection of data throughout the course of a clinical trial. This person: | '''Data manager''' – manages the collection of data throughout the course of a clinical trial. This person: | ||
| + | <!--T:15--> | ||
:*Enters the data | :*Enters the data | ||
| + | <!--T:16--> | ||
:*Works with the principal investigator and research nurse to identify what data will be tracked | :*Works with the principal investigator and research nurse to identify what data will be tracked | ||
| + | <!--T:17--> | ||
:*Provides data to monitoring agencies | :*Provides data to monitoring agencies | ||
| + | <!--T:18--> | ||
:*Prepares summaries for interim and final data analysis | :*Prepares summaries for interim and final data analysis | ||
| + | <!--T:19--> | ||
'''Staff physician or nurse''' – helps take care of the patients during a clinical trial. This person: | '''Staff physician or nurse''' – helps take care of the patients during a clinical trial. This person: | ||
| + | <!--T:20--> | ||
:*Treats patients according to the clinical trial protocol | :*Treats patients according to the clinical trial protocol | ||
| + | <!--T:21--> | ||
:*Assesses and records how each patient responds to the treatment and the side effects they may have | :*Assesses and records how each patient responds to the treatment and the side effects they may have | ||
| + | <!--T:22--> | ||
:*Works with the principal investigator and research nurse to report trends of how patients are doing on the treatment | :*Works with the principal investigator and research nurse to report trends of how patients are doing on the treatment | ||
| + | <!--T:23--> | ||
:*Manages each patient’s care | :*Manages each patient’s care | ||
</translate> | </translate> | ||
Latest revision as of 21:17, 29 October 2019
Research Team Members
Designing and running a clinical trial requires the skills of many different types of experts. Each team may be set up differently at different sites. Typical team members and their responsibilities include:
Principal investigator – supervises all aspects of a clinical trial. This person:
- Develops the concept for the trial
- Writes the protocol
- Submits the protocol for the Institutional Review Board (IRB) approval
- Directs the recruitment of patients
- Manages the informed consent process
- Supervises data collection, analysis, interpretation, and presentation
Research nurse – manages the collection of data throughout the course of a clinical trial. This person:
- Educates staff, patients, and referring health care providers about the trial
- Communicates regularly with the principal investigator
- Assists the principal investigator with the informed consent process, study monitoring, quality assurance, audits, and data management and analysis
Data manager – manages the collection of data throughout the course of a clinical trial. This person:
- Enters the data
- Works with the principal investigator and research nurse to identify what data will be tracked
- Provides data to monitoring agencies
- Prepares summaries for interim and final data analysis
Staff physician or nurse – helps take care of the patients during a clinical trial. This person:
- Treats patients according to the clinical trial protocol
- Assesses and records how each patient responds to the treatment and the side effects they may have
- Works with the principal investigator and research nurse to report trends of how patients are doing on the treatment
- Manages each patient’s care
