Introduction to Alliance Audit

Transcription

1 Introduction to Aiance Audit Scott Okuno, MD Audit Committee Chair Audit Preparation Workshop, November 1, 2018

2 Why Do Audits? Investigators of cinica trias have an obigation to take appropriate steps To protect human subjects who participate in research studies To protect the integrity of the science of cancer studies

3 Reguatory Pharmacy Case Review Components

4 Goa of Audit Quaity Assurance Rue of Fraud/Fasification Educationa

5 Data Set Integrity of Science The integrity of a data set is a function of the entire process Data coection Data anaysis Detaied pans and systems are needed to assure Protoco adherence Uniform coection of data

6 Audit: Quaity Improvement Detect honest errors Systemic repeated errors Misunderstanding of what is to be entered Misunderstanding of how the study is to be conducted Random data entry errors Data from wrong dates Transposition of numbers Missing data Data just does not make sense

7 Data Submission Human Subjects/Integrity of Science Is the Time Tabe for data submission being foowed as specified in the protoco With each cyce? Within specified weeks / months of study entry, treatment or competion of a study therapy? Are the specified data being submitted? Operative reports, path reports, fow sheets, forms, etc. Are the data just not submitted? Has the site been timey in response to queries?

8 Detection of Fasification Hopefuy rare event, however. Bezwoda et a: High-dose chemotherapy with hematopoietic rescue as primary treatment for metastatic breast cancer: A randomized tria. J Cin Onco 1995, 13: [High dose chemotherapy] resuts in a significant proportion of CRs and increased surviva in patients with metastatic breast cancer

9 Fasification Weiss RB, et a: An on-site audit of the South African tria of high-dose chemotherapy for metastatic breast cancer and associated pubications. J Cin Onco 2001; 19: the mutipe pubications of this study do not report verifiabe data, and 9 other pubications co-authored by the principa investigator contain at east one major untrue statement Bezwoda in a document sent to his coeagues: Acknowedged that he committed a serious breach of scientific honesty and integrity by misrepresenting the resuts of that tria Resigned his position at the university

10 Other Exampes Fasification A CRA was found guity of fasifying the data in the study records of 35 patients on the SWOG SELECT tria for prostate cancer prevention Drug Company Study of a toxicity protectant The CRPs at 4 participating institutions fasified at east one QOL document that was to be competed by the patient Three CRPs competed the form and signed the patient s signature One CRP used one form signed by the patient, changed the date with white-out, and submitted as the form for a ater date

11 Audit for Cause Any time concerns are raised regarding the conduct of cinica trias at a site there can be an audit for cause This invoves a more thorough scrutiny, e.g. A subjects entered on a protocos A subjects entered on a specific protoco Drug accountabiity, etc. Cinica Trias Auditing Branch (CTMB) of the NCI is notified and is present at the Audit Charges may be brought against individuas or institutions and may resut in Fines, sanctions (e.g. oss of NIH funding) Loss of empoyment, Loss of Licensure, etc. Imprisonment depending on nature of fraud

12 Audit = Quaity Assurance Dr. Curtis Meinert defines QA as: Any method or procedure for coecting, processing, or anayzing study data that is aimed at Maintaining or enhancing their reiabiity and vaidity Incudes prevention, detection, and action from the beginning of data coection through pubication of the resuts to assure Unbiased treatment assignment Adequate assessment of eigibiity Compiance with protoco treatment Compiance with reguatory requirements Compete coection of data on the primary outcome measures

13 AUDIT Coud/Shoud = Educationa Process Audit team members shoud share practices that have been successfuy impemented at other institutions Cinica practice techniques Data management systems Quaity contro systems Goas of the oca staff Use the resuts of the on-site audit to identify operationa areas where improvements coud be made Corrective and Preventative Action Pan In response to written findings of the audit To incorporate best practices in conduct of cinica trias

14 Aiance - Audit Program Foow CTMB Guideines and Code of Federa Reguations Utiize Aiance Poicies and Procedures A institutions entering at east one (1) patient are subject to audit at a maximum interva of 36 months New main member institutions are audited within 18 months after entry of the first patient, uness accrua has been robust

15 Aiance - Audit Program Institutions withdrawing are sti subject to audit of their entries since the previous audit A institutions are subject to audit during any one year Re-audits are done when accrua is sufficient to make them worthwhie, generay within 12 months Specia Audits / Audits for Cause Irreguarities in quaity contro procedures Aegations of scientific misconduct

16 Aiance - Audit Program Date of Audit is arranged ~4-6 months in advance Mutuay convenient time Geographica & other considerations may affect scheduing Audit team usuay comprised of a CRP/RN, or MD/CRP Team eader a member of the Audit Committee (AC) Ad hoc auditors are invited to participate Ad hoc auditors aways work with a AC member

17 Aiance - Audit Program NCI representative may aso be present More commony with Re-Audits Audit the work of the auditors Audit the process of the audit NCI representative aways there if Audit for cause Specia Audit

18 Aiance - Audit Program Protoco Seection Statistica Office seects protocos for review Minimum of 4 protocos representing studies conducted at the site May incude: IND trias e.g. investigationa drug in use Muti-modaity studies Designated prevention trias Trias with high accruas CTSU studies

19 Aiance - Audit Program Protoco Seection A minimum of 10% of patients accrued since ast audit wi be reviewed (10% each from Aiance, CTSU, DCP, Advanced Imaging) At east 1 case per NCI code for registration trias Most seected from patients accrued since previous audit However, any patient case is eigibe for seection At east 1 unannounced case per NCI code wi be reviewed if the tota accruas warrant May conduct imited review (e.g. eigibiity, consent, data quaity etc.) or fu review of the unannounced case Limited review, does not count in minimum 10%

20 In summary Why Do We Do Audits? To assure a patient protection measures are foowed IRB foowing the Code of Federa Reguations (CFR) mandates ICC compete and foows mode consent To assure a pharmacy procedures are foowed To hep provide assurance the study resuts are vaid To find and correct errors To find missing data, if it exists To discourage fraud and find its rare instances To educate a invoved in cinica trias research regarding protoco adherence and data coection

21 Review of Past Audits: IRB

22 Review of Past Audits: Pharmacy

23 Review of Past Audits: PCR

24 2018 Group Meeting November Chicago, IL