Penn CTMS Frequently Asked Questions
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How do I get Access to the Penn CTMS?If you are an existing ACC Velos user you will maintain access to PennCTMS. A script will be sent out to all existing users to complete in January 2017 which will fulfill training requirements. If you are a new users you must submit the following access form to email@example.com and complete in person training which can be found in Knowledge Link under Penn CTMS: New User training. If you have any access or training questions , please contact firstname.lastname@example.org.
Does my study need to be registered in the Penn CTMS?Below is a depiction of the type of studies that should be entered into the Penn CTMS and the varying levels of data that need to entered.
NOTE: All cancer relevant studies are required to register their study in PEnnCTMS and enter all data needed for NCI reporting requirements, per the current process in the ACC.
Non Exempt human subjects research studies: Must be registered in the Penn CTMS and study status kept up to date. To accomplish this study registration and study management training is needed.
Studies which require consent (verbal or written):
- Must be registered in the Penn CTMS.
- Study status must be kept up to date and subjects must be enrolled on the study and their status tracked.
- These types of studies require study registration training, study management training and patient management training.
Studies with prospective interventions require study creation, management, patient enrollment, tracking of patients and adverse event collection and management. These types of studies require study registration training, study management training and patient management training.
For any studies using hospital services. PennChart build is required. These studies can be registered in the PennCTMS and the study can be sent to PennChart. This process is covered in the patient management training.
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How will current users be impacted by the enterprise Penn CTMS?For the most part, the current system has not changed significantly. There are, however, a few changes everyone should be aware of:
- IRB number, not UPCC or Co-Op number, will be used as the Study Number.
- The patient and study status values have been updated to reflect the broader number of studies using the system.
- There have been changes to what data is collected on the study summary screen.
- The steps for registering a new Penn Medicine patient have changed now that PennCTMS will be linked to PennChart.
How is PennCTMS different than HSERA, PennERA, Oracle Clinical, PennChart and other research systems?PennCTMS is the only Clinical Trial Management System in use at Penn Medicine. HSERA and PennERA are University systems focused on specific areas, such as IRB reviews and finances. Oracle Clinical is used for clinical data management. PennCTMS offers functionality to manage electronic patient enrollment, integration with PennChart for tracking patients enrolled on studies, and adverse event tracking and reporting. These are capabilities, available to all clinical trials, which are not available in the other tools.
How is PennCTMS different than Velos?PennCTMS is based on the Velos eResearch application that has been in use in the Abramson Cancer Center for over 7 years. For over a year, PMACS and the Office of Clinical Research have been meeting with many individuals involved in clinical research at Penn Medicine. The goal has been to identify the types of changes needed to enable Velos to work with a larger set of studies beyond the ACC.
How will current users be impacted by the enterprise Penn CTMS?For the most part, existing users and studies will notice very few changes to the system. There are, however, a few changes everyone should be aware of:
- Re-training is required for existing users and new users will need to sign up for new user training. This can be accomplished via sign up through Knowledge Link, for in person training, or completion of work instructions and a detailed script. Contact OCR if you have questions.
- For new multi site studies, external users will need to apply, via the research team, for a temporary Penn ID and use that for logging into the system. They will also require online training to achieve access
- Additional fields will appear on the study summary screen.
- For studies using hospital services and/ or that require the use of PennChart- the study can be created in PennCTMS and sent to PennChart. Patients can then be enrolled in PennChart and their status sent back and tracked in Penn CTMS.
Need help? Submit a KACE ticket: https://helpdesk.pmacs.upenn.edu/
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