Research Note Checklist | ||
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Visit Type | Yes | N/A |
Initial Visit/Screening Visits | ||
Document discussion of protocol(s), associated schemas, adverse events, disease response follow-up, clinic visits, labs, etc. | ||
Document that copy of the appropriate consent form(s) given to subject to review. | ||
Document the consenting process, that subject signed consent and that a copy of the signed informed consent form was given to subject. | ||
Document tests done and/or pending. | ||
Document any concerns that the subject and/or family has and how addressed. | ||
On Study Visit/Eligibility Confirmation | ||
Document that eligibility is met (including performance status and life expectancy as applicable per protocol) and verified by the PI or designee. | ||
Document that all appropriate baselines testing was completed and ensure that the results are in the medical record (not just verbal communication; hard copy needed). | ||
Document all baseline symptoms including approximate start date (month & year). | ||
Document all concomitant medications including: dose, frequency, route, indication and approximate start date (month & year; number of years on conmed). | ||
Document participant education including review of diary or survey, how to complete, when to return, etc., if applicable. | ||
On Treatment/On Study Visits | ||
Review and ensure documentation of physical exams including performance status. | ||
Review and document all adverse events including: date started, date stopped, description of severity, how treated if applicable, and attribution to study/drug. | ||
Review and document all concomitant medications including: which drugs are still ongoing, any dose changes with ongoing meds, addition of new meds including dose, frequency, route, indication and start date. | ||
Review and document compliance with protocol (i.e.: subject self-administration of study meds, tests/procedures conducted, tests/procedure missed and why). |
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Review and ensure that there is documentation of disease/response assessment including results of scans/labs and decision to stay on/off treatment/study. | ||
Review and ensure that the research bloods (PKs, PDs, etc) drawn, study agents and pre/post-medications given are appropriately documented in the medical record. | ||
Telephone Calls | ||
Document reason for call (adverse event, general question, test result, etc.) | ||
Document outcome of call (how adverse event to be treated, etc.) | ||
Off -Treatment Note | ||
Document reason off-treatment, including date. | ||
Document any follow-up that needs to occur. | ||
Document return of drugs, if applicable. | ||
Note any ongoing AEs and continue to follow if related to study. | ||
Notes During Follow-up Period | ||
Review and document all protocol-specific activities that occur in the follow-up period (e.g., phone call for survival, adverse events (new and/or unresolved), physical exams, response). | ||
Document all attempts of contact for follow-up visits. | ||
Off-Study Note | ||
Document reason off-study, including date. |