CRA Interview – Flashcards

"Measured via CT (or X-ray or MRI) the longest diameter of a tumor • CR (complete response) = disappearance of all target lesions • PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions • PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions • SD (stable disease) = small changes that do not meet above criteria

"Adverse Event Grading System for cancer studies 0-4 (0 is usually = None, 4 is life threatening or death)

"Confirmation Letter Sign site visit log except at Pre-Study Visit Follow up letter

"Evaluate Investigator, Staff, Facility (tour what type of storage/freezer type space available), IRB (central or local), lab (local or central) and Protocol feasibility (experience w/ similar studies, competing studies, availability of potential subjects etc.) Review Investigator and Staff Qualifications Gauge general interest and attitude Review Licenses (Medical Licenses, Nurse etc)

"Confirm receipt of Supplies Review protocol Review CRF completion/train on CRFs Confirm all startup reg. docs are on file Establish Monitor visit frequency

"Review site status/ECRFs Prior to visit Review protocol compliance - primarily inclusion/exclusion criteria Review ICFs (informed consent forms) Source document verification (compare source documents to CRFs) Check for new AEs/SAEs Review study drug accountability, storage, dispensing & any temperature excursions Assure any safety update letters have been sent to the IRB - lots in Oncology trials Review regulatory binder Collect any new documents (original 1572 sent to Sponsor) Complete Monitoring Report w/in 10 business days

"Ensure Regulatory documents on site match in house file Ensure all CRFs are complete and submitted to sponsor All queries are addressed AE/SAE follow up is complete All signed informed consent forms (ICFs) are filed Ensure Study drug logs are complete & all study drug returned to sponsor per instructions Ensure investigator brochure and study materials are filed together Review long term storage FINAL REPORT IS COMPLETED AND SUBMITTED TO IRB & SPONSOR (usually a form provided by IRB)

"Transitioned from the Financial Industry to the Pharmaceutical industry after 11 years to work at Pharma Monitors as the Business person. Pharma Monitors is a family owned contract monitoring company. I started going on Co-Monitoring visits to help me better understand our company and I found that I really enjoyed it. During the time period I was Co-Monitoring I was training on FDA guidelines and GCP's and taking classes at a community college on Medical Terminology, Pathophysiology, etc. After about 6 months of Co-Monitoring and training I started conducting individual monitoring visits due to the increased business. I also decided at this time to pursue a degree in Clinical Research Administration so I took classes online at the George Washington University. Finished my B.S. in May 2010. When the recession hit I decided to pursue a position with more stability and started in Project Management at Pacific BioMarkers, Inc. We did some work with ICON. Unfortunately due to the economy and poor business planning, PBI had to downsize and so I went back to Pharma Monitors.

" Inform and some RAVE, in addition I have been using Impact a trial management system for report writing and submission.

Common Toxicity Criteria

Source Data Verification

Pre-Study Visit

Study Initiation Visit

Interim Monitoring Visit

Close Out Visit

"Death Life threatening Hospitalization Persistent or significant disability or incapacity Judged serious by the Investigator, Sponsor or FDA Congenital anomalies or birth defects

Collect SAE's from time of consent.

Collect AE's from time of study drug unless caused by a study procedure (screening procedure).

Site to inform Sponsor within 24hrs of finding out & notify IRB (different timelines for different IRBs)

"Statement that research is involved Expected Adverse events or what the subject can reasonably expect as side effects Statement that the subject can withdraw at any time A description of the study A statement of the subjects privacy and confidentiality

"Protocol Protocol Amendments & Signature page(s) Investigator's Brochure (IB) IB updates Site SAE information IND Safety Reports FDA Form 1572 - Original sent to sponsor Medical Licenses and CVs Financial Disclosures IRB Information Site IP Inventory Log Site Visit Log Corespondence

...

"Measured via CT (or X-ray or MRI) the longest diameter of a tumor • CR (complete response) = disappearance of all target lesions • PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions • PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions • SD (stable disease) = small changes that do not meet above criteria

"Adverse Event Grading System for cancer studies 0-4 (0 is usually = None, 4 is life threatening or death)

"Confirmation Letter Sign site visit log except at Pre-Study Visit Follow up letter

"Evaluate Investigator, Staff, Facility (tour what type of storage/freezer type space available), IRB (central or local), lab (local or central) and Protocol feasibility (experience w/ similar studies, competing studies, availability of potential subjects etc.) Review Investigator and Staff Qualifications Gauge general interest and attitude Review Licenses (Medical Licenses, Nurse etc)

"Confirm receipt of Supplies Review protocol Review CRF completion/train on CRFs Confirm all startup reg. docs are on file Establish Monitor visit frequency

"Review site status/ECRFs Prior to visit Review protocol compliance - primarily inclusion/exclusion criteria Review ICFs (informed consent forms) Source document verification (compare source documents to CRFs) Check for new AEs/SAEs Review study drug accountability, storage, dispensing & any temperature excursions Assure any safety update letters have been sent to the IRB - lots in Oncology trials Review regulatory binder Collect any new documents (original 1572 sent to Sponsor) Complete Monitoring Report w/in 10 business days

"Ensure Regulatory documents on site match in house file Ensure all CRFs are complete and submitted to sponsor All queries are addressed AE/SAE follow up is complete All signed informed consent forms (ICFs) are filed Ensure Study drug logs are complete & all study drug returned to sponsor per instructions Ensure investigator brochure and study materials are filed together Review long term storage FINAL REPORT IS COMPLETED AND SUBMITTED TO IRB & SPONSOR (usually a form provided by IRB)

"Transitioned from the Financial Industry to the Pharmaceutical industry after 11 years to work at Pharma Monitors as the Business person. Pharma Monitors is a family owned contract monitoring company. I started going on Co-Monitoring visits to help me better understand our company and I found that I really enjoyed it. During the time period I was Co-Monitoring I was training on FDA guidelines and GCP's and taking classes at a community college on Medical Terminology, Pathophysiology, etc. After about 6 months of Co-Monitoring and training I started conducting individual monitoring visits due to the increased business. I also decided at this time to pursue a degree in Clinical Research Administration so I took classes online at the George Washington University. Finished my B.S. in May 2010. When the recession hit I decided to pursue a position with more stability and started in Project Management at Pacific BioMarkers, Inc. We did some work with ICON. Unfortunately due to the economy and poor business planning, PBI had to downsize and so I went back to Pharma Monitors.

" Inform and some RAVE, in addition I have been using Impact a trial management system for report writing and submission.

Common Toxicity Criteria

Source Data Verification

Pre-Study Visit

Study Initiation Visit

Interim Monitoring Visit

Close Out Visit

"Death Life threatening Hospitalization Persistent or significant disability or incapacity Judged serious by the Investigator, Sponsor or FDA Congenital anomalies or birth defects

Collect SAE's from time of consent.

Collect AE's from time of study drug unless caused by a study procedure (screening procedure).

Site to inform Sponsor within 24hrs of finding out & notify IRB (different timelines for different IRBs)

"Statement that research is involved Expected Adverse events or what the subject can reasonably expect as side effects Statement that the subject can withdraw at any time A description of the study A statement of the subjects privacy and confidentiality

"Protocol Protocol Amendments & Signature page(s) Investigator's Brochure (IB) IB updates Site SAE information IND Safety Reports FDA Form 1572 - Original sent to sponsor Medical Licenses and CVs Financial Disclosures IRB Information Site IP Inventory Log Site Visit Log Corespondence