As we prepare to ramp up services in the PET Center, new procedures are required for the safety of our patients, research subjects, and personnel, which include pre-screening for COVID-19 and facilitating contact tracing, if needed. In order to implement these safety procedures, research subjects must be registered in EPIC with valid medical record numbers (EMPI) to schedule and order research PET and PET/CT scans.
The following statements should be added to the ICF customized to your study:
Your participation in this research study will be documented in your electronic medical record. This record can be viewed by authorized personnel from Columbia University Irving Medical Center, Weill Cornell Medical Center, and NewYork-Presbyterian Hospital and its affiliated institutions, because these institutions share the electronic medical record system. Study monitors and others who provide oversight of the study may also need to access this record. [Add, as applicable, tailoring to the situation: Results of your research tests, including scans, (will) (will not) be returned to you and they will not be documented in the EMR. Research tests are those that are conducted solely for research and would not be conducted if you were not in this study.]
For participants who are already enrolled, and with the approval of the external sponsor, if applicable, an addendum to the consent form can be used to provide this information. IRB will allow the use of the addendum without the submission of a modification.
IRB approval is required for consent form changes.
There are several options available:
- Departmental front desk personnel who are trained in Epic for Registration are able to provide an EMPI for a new research subject.
- Research personnel may contact central registration at 305-6571 / 305-3208 to register a new subject in EPIC.
- Training in EPIC for Registration (Prelude Application) of new subjects is also available. Contact EpicTogetherNYTraining@nyp.org for training.
The research scan will be ordered with the research subject’s EMPI instead of the generic patient. The ordering process is the same where you will be required to select your procedure listed below and corresponding IRB when prompted:
- IMG3693 - PET-CT Research
The process remains the same for scheduling.
If the study meets all of the following criteria, the subjects do not need to be registered in CTMS:
- The research scan is conducted at PET Center; and
- The scan(s) is billed to the research grant; and
- The study does not require other tests, procedures performed at NYP, CRR, or CUIMC.
If the study is a clinical trial or have research billable events at NYP or CUIMC, contact the Clinical Trials Office for study registration in IBM CTMS. (firstname.lastname@example.org)