Benaroya Research Institute at Virginia Mason

Benaroya Research Institute at Virginia Mason

Consent Process Checklist

Study#: Date

Patient Name/ID: MRN#

Basic Eligibility Topics for Discussion:

□Describe the reason for study and that it is considered research

□ Time commitment, # of visits, screening and study procedures, blood draws expected during

the course of the study

□ Reviewed exclusion/Inclusion criteria

Items still needed:

□ Importance of compliance with visits and therapy

□ Discussed risks and benefits of study

□ Alternative Therapies discussed by licensed practitioner

□ Subject understands if they choose not to participate in the study (or can discontinue at any

time)they will not lose the best medical care VM can provide.

□ Providedconsent and HIPAA authorization forms & confidentiality of records

□ Potential expenses associated with study (and any reimbursement) discussed

□ Whom to contact with questions

□ Opportunity to read and ask questions about the study

Questions:

□ Answered all questions about study

□ Subject signed all applicable consent(s) and HIPPA Authorization forms

□ Other:

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Comments: (Example of enhanced or strengthened documentation)

‘Date’

Subject is a 52 yo cauc female screening for the study mentioned above. Following discussion with ‘MD’ regarding alternative therapies, the study was of interest to the subject and the details reviewed as mentioned above. Specifically, the potential side effects of nausea, vomiting, diarrhea and myalgias were reviewed, however, the subject understands that a rash may develop and should contact the investigator if accompanied by a fever. Subject was able to read the consent, asked a couple of questions including if they were interested in discontinuing due to an AE, could they still receive the standard chemotherapy treatment. Subject was reassured by the MD and subject then signed the informed consent. Subject received a copy of the signed consent and history, con med review and initial PE were completed. Subject understands that the CXR, ECG and Lab values must be normal before enrollment onto the study and should be completed prior to leaving the clinic today. Will contact the subject to confirm eligibility into the study, but have asked the subject to contact the investigator, clinic staff with health issues or myself with questions regarding the study or continued participation.

The consent process documentation may include the following:

Study Schedule

Potential Risks

Read and Asked questions

Signed copies of the consent to subject

Consent signed prior to initiation to study procedures/tests

Who to contact with questions

Signature of Person Conducting Consent: Date:

FRM 0031.BPage 1 of 1Effective Date: 31-Oct-2011