What is IR Trace: You got an error message. IR hangs up. Unable to produce reports, Don’t know what caused IR to misbehave. Trace is where you get the details for debugging. This is what IR support team wants to see when you report a problem.
Follows these steps to run a Trace:
1. Close any open IR session.
2. Locate review32.ini file (Generally located under c:/windows/review32.ini )
3. Open the file in notepad.
4. In the [client] section of this file, add the line TRACE=ON (as shown below)
5. Save the changes. Close review32.ini file.
6. Log in to IR as usual.Go through as minimal steps as possible to reproduce the error message(s). Click ok through all message boxes, then immediately log out of the application.
7. Under the client installation directory (default c:/ireview) you will find an objstore subdirectory. In that subdirectory, you will have a trace.log file.8. Send trace.log file to IR support , along with a brief description of what steps you took to get the error.
Please note, running a trace in J-Review is different.
IB (Investigator’s Brochure) update contains
- Dose (of the study drug)
- Frequency of dosing interval
- Methods of administration
- Safety monitoring procedures
An IB contains a “Summary of Data and Guidance for the Investigator” section, of which the overall aim is to “provide the investigator with a clear understanding of the possible risks and adverse reactions, and of the specific tests, observations, and precautions that may be needed for a clinical trial. This understanding should be based on the available physical, chemical, pharmaceutical, pharmacological, toxicological, and clinical information on the investigational product(s). Guidance should also be provided to the clinical investigator on the recognition and treatment of possible overdose and adverse drug reactions that is based on previous human experience and on the pharmacology of the investigational product”.
The sponsor is responsible for keeping the information in the IB up-to-date. The IB should be reviewed annually and must be updated when any new and important information becomes available, such as when a drug has received marketing approval and can be prescribed for use commercially.