Can we reuse a randomization number if the patient does not receive drug?
No. Once a randomization number is assigned the patient must be followed for an intention-to-treat analysis • Do we stop drug if there is an anaphylactic reaction to another drug? No. The anaphylaxis would be recorded as a serious adverse event and study drug administrations could continue. The coordinating center should be notified by fax within 48 hours of the event. • DNR exclusion clarification. If a patient is DNR (s)he should not be entered into the study. • Regarding the information describing the procedure for preparation and freezing of t-PA sent to each site by the Johns Hopkins Investigational Drug Service. The “special technique” described goes a step beyond the standard sterile preparation by transferring the preparation to a sterile syringe by a “sterile pharmacist” and packaging the final product in sterile packaging. Do we have to use this procedure and if so, it will increase our costs? When the information was sent the following statement was issued: “The following pr
Related Questions
- A patient came in for a blood draw prior to randomization and a CALGB patient ID number has not been assigned yet, what do I do with the sample?
- At END of Study - can the patient continue getting investigational drug –if it is beneficial to patient?
- Can a Physician or Patient reuse the appropriate eye protection?
