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Research Note Checklist
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).

   
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.    
Last updated by Richman, Michele (NIH/NCI) [C] on Jun 17, 2014