Study Entry (Screening or Baseline Visit) Template
Date:
PI & Treating Investigator:
Coordinator:
Study Title:
BRI Study #:
Study Synopsis:
Possible AEs expected:
Study Visit Schedule: (may include # and frequency of blood tests, scans, visits or
treatments)
Consent Documentation:
Subject has been verbally informed of the study specifics and has been
given the opportunity to ask questions. All questions were answered to the subject’s satisfaction. It was clearly stated that the study was voluntary and that they could withdraw anytime. The subject agreed to participate in the XXX study and has signed the Consent Form on dd/mmm/yyyy. A copy of the consent form was given to the subject.
Inclusion/Exclusion:
Subject has met inclusion, exclusion criteria. All related study procedures have been completed. History, concomitant medications and baseline symptoms have been captured.
Expected enrollment date and experimental treatment information:
- Randomization information (may include kit #, bottle # or implant registration information)
Interim Visit Evaluation
Date:
PI & Treating Investigator:
Coordinator:
Study Title:
BRI Study #:
Subject was:
- Seen today for an interim study visit and continues to do well.
- Restaged on dd/mmm/yyyy and remains stable.
Reconsent
A revised informed consent was presented to the subject. The new information was reviewed with the subject and they had the opportunity to ask questions. The subject signed the revised consent form and was given a copy.
The subject reports the following:
Serious Adverse Events (SAE):
Adverse Events(AE) (start/stop dates, severity, relatedness):
Concomitant Medication Changes:
Dosing or device modifications:
The subject will continue on study per protocol and understands to contact the clinic with any medical concernsor the research coordinator with any study related questions.
Study Completion – Active Intervention
Date:
PI & Treating Investigator:
Coordinator:
Study Title:
BRI Study #:
The subject is
- Completing the active portion of the study
- Has completed the study as outlined
- Completing early due to…
On-going events that need to be followed:
Serious Adverse Events (SAE)
Adverse Events (AE) (start/stop dates, severity, relatedness):
The last day of the study therapy was dd/mmm/yyyy. Study follow-up will occur at X days as outlined in the protocol.
The subject understands to contact the research coordinator with any study related questions.
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Follow-Up Visit
Date:
PI & Treating Investigator:
Coordinator:
Study Title:
BRI Study #:
The subject is continuing long-term follow-up for the study. Subject continues to do well with minor symptoms related to their disease.
Note to File Documentation TemplatePRINT ON
LETTERHEAD
DATE
Note To File
STUDY:Protocol Title
PI/Coord:
RE:Summary of the Note
BRI#:
TEXT: Describe the events along with any corrective action taken. If applicable, propose any preventative action planned to mistake proof the process in the future.
Sincerely,
NameName
Principal InvestigatorStudy Coordinator
Attachments or Enclosures: