Step one: share the good news! It is the PI’s responsibility to share any IRB-related updates with your Research Study Team. But your responsibilities don’t stop there: Once the IRB has approved your consent form for CMH patients, do not distribute consent forms to patients until you have received the PDF version of the consent form from the IRB with barcodes. Pro Tip: print the form instead of copying it multiple times, which reduces the barcode quality. Ensure that the IRB study number/consent form version date is formatted onto each page of the consent form submitted to the IRB. According to this policy, if your study requires funding from GME, you need to submit your budget for approval to the ADGME. Please see “What if my study needs funding” for more information. PI responsibilities after IRB approval: Liaise between Research Study Team and IRB; Oversee enrollment (making sure that only those with IRB approval are enrolling subjects), data protections, and  HIPAA protections; Order any necessary labs/tests beyond standard of care ONLY IF cost is covered for the patient Immediately report to the IRB any: Conflicts of Interest Protocol deviations resulting in an Adverse Event / Serious Adverse Event (as well as a statement on the corrective action plan taken for the incident) Adverse Events/Serious Adverse Events (regardless of cause) Significant findings that occur during the study that might affect subjects’ decisions to participate or continue participating Death of a subject (regardless of cause);  Discuss with the GME Research team any changes in study protocol AND submit any amendments to IRB *prior to* implementing any changes, including modifications in PI, research team, and protocol (including: title, sites, subjects, consent form, recruitment, enrolment, consenting, data collection methods/tools, changes in funding, changes in Conflicts of Interest among Research Study Team members).  Respond to any IRB inquiries. Based on your study type, you may expect to be contacted by the IRB for a Continuing Review – a general check in on how your study is going and if any changes need to be made to your protocol.  Close or hand off the study once it is appropriate. If you are closing the study, notify the IRB and submit a final report (see sections “My study has been completed” and “I’m graduating”).  If you are graduating and will not have a chance to complete the project, identify who will take over the study.