1. Eligibility: The deciding factor

2. Eligibility Criteria Select subjects that are as homogenous as possible Select subjects that are as homogenous as possible Control and build variables into the design of the study Control and build variables into the design of the study Answer the trials hypothesis and meet written objectives Answer the trials hypothesis and meet written objectives Patient safety Patient safety

3. Eligibility Criteria The Good, The Bad and The Ugly Writing eligibility criteria is an art: Must not be overly restrictive Must not be overly restrictive Must not be overly vague Must not be overly vague Must be verifiable Must be verifiable Must be based on “reasonable” practice parameters Must be based on “reasonable” practice parameters Must not be excessive in number Must not be excessive in number

4. Eligibility Criteria The Good, The Bad and The Ugly Overly Restrictive: Must be 18 years of age Must be 18 years of age HIV test within 14 days of study entry HIV test within 14 days of study entry

5. Eligibility Criteria The Good, The Bad and The Ugly Overly Vague: Patients on anticoagulation therapy are allowed to have an appropriately prolonged International Normalized Ratio (INR) Patients on anticoagulation therapy are allowed to have an appropriately prolonged International Normalized Ratio (INR)

6. Eligibility Criteria The Good, The Bad and The Ugly Difficult to verify: THE GOLDEN RULE If the investigator feels that it is important enough to list it as a stand-alone criterion, an audit should feel that it is important enough to source verify If the investigator feels that it is important enough to list it as a stand-alone criterion, an audit should feel that it is important enough to source verify

7. Eligibility Criteria The Good, The Bad and The Ugly Difficult to verify: History of XXX lesion with large necrotic areas, as determined by the Principal Investigator History of XXX lesion with large necrotic areas, as determined by the Principal Investigator Life expectancy of >12 weeks Life expectancy of >12 weeks

8. Eligibility Criteria The Good, The Bad and The Ugly Reasonable practice parameters: Patient must be willing to stay within 5 miles of the hospital and return daily for labs. Patient must be willing to stay within 5 miles of the hospital and return daily for labs.

9. Eligibility Criteria The Good, The Bad and The Ugly Excessive number: Average number of eligibility criteria per protocol is 28 Average number of eligibility criteria per protocol is 28

10. Source Document: In a clinical trial, source documents are the hard copies on which clinical observations are first recorded. They are legally valid raw data that support a study’s findings. In a clinical trial, source documents are the hard copies on which clinical observations are first recorded. They are legally valid raw data that support a study’s findings.

11. What Source Documents Do We Look for When Assessing Eligibility? Histology: Histology: CT/CXR, MRI, PET scans: CT/CXR, MRI, PET scans: Labs: Labs:

12. What Source Documents Do We Look for When Assessing Eligibility? For compound criteria: Histologically or cytologically documented adenocarcinoma of the pancreas not amenable to surgical resection: Histologically or cytologically documented adenocarcinoma of the pancreas not amenable to surgical resection:

13. What Source Documents Do We Look for When Assessing Eligibility? For the “vague-ities”: Patients have recovered from any surgical procedure Patients have recovered from any surgical procedure

14. What Parameters Do We Look for When Assessing Eligibility? Did all testing meet the assigned value/intent of the criteria? (CT measurements, labs) Did all testing meet the assigned value/intent of the criteria? (CT measurements, labs) Did on-study note clearly address each “non- measurable” criteria? (date since last chemo, PS, con meds, etc). Did on-study note clearly address each “non- measurable” criteria? (date since last chemo, PS, con meds, etc). If patient did not meet criteria was wiaver appropriately used ? (NCI) If patient did not meet criteria was wiaver appropriately used ? (NCI)

15. AUDITING HINTS Eligibility criteria are critical; take them seriously Eligibility criteria are critical; take them seriously Read the protocol, know the criteria Read the protocol, know the criteria Develop a tool to capture components Develop a tool to capture components --Study calendar (when things should occur) --Table --Excel spreadsheet Calendar for time patient is on trial (when things actually occur) Calendar for time patient is on trial (when things actually occur) Review how research nurse captures data and sets up research files Review how research nurse captures data and sets up research files Create uninterrupted time Create uninterrupted time

16. DEAL or NO DEAL ? YOU DECIDE

17. Criteria: Ambulatory, medically stable persons; community dwelling; able to give informed consent and available for all study visits; able to understand and comply with planned study procedures; ECOG performance status < 2. Ambulatory, medically stable persons; community dwelling; able to give informed consent and available for all study visits; able to understand and comply with planned study procedures; ECOG performance status < 2.

18. Criteria: Patients may have received one systemic chemotherapy regimen for XXXX tumor. There is no limit to the number of biological or immunotherapeutic regimens received by patients. Patients may have received one systemic chemotherapy regimen for XXXX tumor. There is no limit to the number of biological or immunotherapeutic regimens received by patients.

19. Criteria: Total bilirubin is less than or equal to 1.5 times the institutional upper limit of normal, SGOT less than or equal to 1.5 times the institutional upper limit of normal.

20. Criteria Patients with active infection Patients with active infection

21. Criteria: History of psychiatric illness/social situation that would limit compliance with study requirements History of psychiatric illness/social situation that would limit compliance with study requirements

22. POINTS TO REMEMBER Your role as an auditor is to: Verify that the investigator is enrolling only eligible subjects [GCP 5.18.4 (i)] Verify that the investigator is enrolling only eligible subjects [GCP 5.18.4 (i)] Protect the rights/well-being of human subjects Protect the rights/well-being of human subjects Ensure the integrity of the data Ensure the integrity of the data Verify that the conduct of the protocol is consistent with the IRB approved protocol, all federal and state regulations, GCP guidelines and institutional policy. Verify that the conduct of the protocol is consistent with the IRB approved protocol, all federal and state regulations, GCP guidelines and institutional policy. Not stated = not verified Questionable data = unacceptable loss

23. PRACTICE TIME