The document discusses internal auditing procedures for clinical research. It provides an overview of why audits are conducted (for compliance, process improvement, and education), who and what is audited, how audits are scheduled and conducted, and the coordinator's perspective on auditing. Key points include that audits assess informed consent, eligibility, protocol compliance, safety, and regulatory compliance; they take place at research sites and are scheduled in advance; and having well-organized documentation and addressing issues proactively helps the audit process go smoothly.
Hanrick Curran Audit Training - Internal Controls - March 2013Matthew Green
Training delivered to assisting audit staff as part of their continuing professional development/education (CPE/CPD). Provided in a 60 minute session with substantial discussion and interaction.
What is the purpose of internal auditing? How important is it to the business? How are internal audits planned and carried out? These slides show the relevance of internal audit to the business, how internal audits relate to the objectives and risks of the business, how they are planned and the work involved in an internal audit. Further advice is available from www.internalaudit.biz
Hanrick Curran Audit Training - Internal Controls - March 2013Matthew Green
Training delivered to assisting audit staff as part of their continuing professional development/education (CPE/CPD). Provided in a 60 minute session with substantial discussion and interaction.
What is the purpose of internal auditing? How important is it to the business? How are internal audits planned and carried out? These slides show the relevance of internal audit to the business, how internal audits relate to the objectives and risks of the business, how they are planned and the work involved in an internal audit. Further advice is available from www.internalaudit.biz
Why is it important to assist your client in the audit process and how can it impact you?
Assisting clients with the audit firm selection process can be an opportunity to add value to your client relationship
Vetting plan audit firms and correspondence may lead to valuable referral relationships
Save clients from the possible risk of fines and penalties
Possible co-fiduciary responsibility in selecting other plan service providers
How to develop a proactive approach for assisting clients with the audit process
Why is it important to assist your client in the audit process and how can it impact you?
Assisting clients with the audit firm selection process can be an opportunity to add value to your client relationship
Vetting plan audit firms and correspondence may lead to valuable referral relationships
Save clients from the possible risk of fines and penalties
Possible co-fiduciary responsibility in selecting other plan service providers
How to develop a proactive approach for assisting clients with the audit process
An Institutional Review Board (IRB), also known as an Independent Ethics Committee (IEC), is a committee responsible for reviewing and approving the ethical aspects of research involving human subjects. IRBs/IECs play a crucial role in protecting the rights, welfare, and safety of research participants. Here are some key points about IRBs/IECs
OCR Audits Are Coming – Is Your Organization Prepared?Polsinelli PC
OCR has finally launched its Phase 2 formal audits of Covered Entities (CEs) and Business Associates (BAs). The first step of an audit will consist of OCR reviewing a CE's policies, procedures, and processes for HIPAA Privacy, Security, and Breach Notification Compliance. If significant noncompliance is uncovered, OCR may probe further with an on-site inspection. Upon notice of an OCR audit, OCR will require CEs and BAs to produce their HIPAA policies, procedures, and other compliance documents within 10 days. If you wait until notice of an audit to shore up your HIPAA policies, procedures and compliance documents, it will be too late. All this occurs under the backdrop of dramatically increased HIPAA enforcement actions by OCR; in the first quarter of 2016 alone, OCR extracted settlements or imposed CMPs in six formal cases ranging from $125,000 to $3.9 million. That is as many settlements as OCR extracted in the entire year of 2015.
How are your HIPAA policies and procedures? Have you ever developed them? Can you find them? Will they pass an OCR review? Has your organization undergone a HIPAA Security Risk Analysis? Has it been updated? An ounce of HIPAA preparation now will save $100,000s in cure later. Polsinelli presents this webinar to explain what to expect from an OCR audit and how to prepare a "HIPAA audit binder" that will put you in a better position to respond to OCR if the agency should come knocking.
DIRECT CARE PROJECT PART 1ASSESSMENT AND DIAGNOSISDirectioAlyciaGold776
DIRECT CARE PROJECT PART 1
ASSESSMENT AND DIAGNOSIS
Directions: Prior to completing this template, carefully review Week 2: Direct Care Part 1 directions and all rubric requirements.
Assessment of Certification, Patient Outcomes, and Leadership
1. State the clinical certification and target population that were approved by your instructor in the Week 2: Direct Care Part 1 Assessment and Diagnosis Check-In.
a. Clinical certification
PCCN
b. Target population including setting
Nurses who provide direct care to acutely ill adult patients regardless of their physical location. My current unit is a MSPCU floor.
2. Discuss why this clinical certification was selected in relationship to the selected setting.
3. Describe the criteria for selected clinical certification
a. Process to obtain clinical certification
b. Cost of application and testing
c. Requirements prior to certification
d. Examination description
e. Renewal time and process
f. Required items for renewal
4. Provide APA reference for one peer-reviewed scholarly professional nursing journal article connecting patient outcomes, clinical certification, and leadership skills. See reference criteria under directions and include Permalink.
5. Summary of article (one to two paragraphs)
6. How could patient outcomes in the selected setting be improved by certified nurses?
7. How can clinical certification impact leadership skills in the selected setting?
Problem Diagnosis Statement
Write a diagnosis based on the problem of knowledge deficit of certifications. Fill in the blanks below.
Example: Knowledge deficit r/t CNOR certification among operating room nurses (target population and setting) as manifested by wrong site surgeries (patient outcomes)
Knowledge deficit r/t __________________certification among __________(target population and setting) as manifested by ___________________(patient outcomes).
Title:
Documentation of problem based assessment of the musculoskeletal system.
Purpose of Assignment:
Learning the required components of documenting a problem based subjective and objective assessment of musculoskeletal system. Identify abnormal findings.
Course Competency:
Demonstrate physical examination skills of the skin, hair, nails, and musculoskeletal system.
Instructions:
Content: Use of three sections:
· Subjective
· Objective
· Actual or potential risk factors for the client based on the assessment findings with description or reason for selection of them.
Format:
· Standard American English (correct grammar, punctuation, etc.)
Resources:
Chapter 5: SOAP Notes: The subjective and objective portion only
Sullivan, D. D. (2012). Guide to clinical documentation. [E-Book]. Retrieved from http://ezproxy.rasmussen.edu/login?url=http://search.ebscohost.com/login.aspx?direct=true&db=nlebk&AN=495456&site=eds-live&ebv=EB&ppid=pp_91
Smith, L. S. (2001, September). Documentation do’s and don’ts. Nursing, 31(9), 30. Retrieved from http://e ...
his guideline should be read in conjunction with other ICH guidelines relevant to the
conduct of clinical trials (e.g., E2A (clinical safety data management), E3 (clinical study
reporting), E7 (geriatric populations), E8 (general considerations for clinical trials), E9
(statistical principles), and E11 (pediatric populations)).
This ICH GCP Guideline Integrated Addendum provides a unified standard for the European
Union, Japan, the United States, Canada, and Switzerland to facilitate the mutual acceptance
of data from clinical trials by the regulatory authorities in these jurisdictions. In the event of
any conflict between the E6(R1) text and the E6(R2) addendum text, the E6(R2) addendum
text should take priority.
1. Internal Auditing in Research:The QA ProcessResearch Education SeriesFebruary 14, 2011 Sarah Dutkevitch, RN, OCN, Clinical Research Nurse Specialist Heather Kemp, MBA, CCRP, Clinical Research Coordinator Department of Surgery, General Surgery Section
2. Agenda / Overview Assessing Risk in Auditing The SOP: Answering the Who, What, Where, When, Why, and How of Internal Auditing The Coordinator’s Perspective: Before, During, and After an Internal Audit
5. Now It’s Your Turn Answer the questions in Section I (page 1) of your handout to assess the context of your research group.
6. Why is it Audited? Compliance Process Improvement Education
7. Who is Audited? All research which: Is not exempt from IRB review; Is not being conducted under a waiver of informed consent; Has subjects enrolled on the study; and Has not been reviewed by the Clinical Trials Monitoring Committee in the past 12 months.
8. What is Audited? Informed Consent Documents and Informed Consent Process Documentation HIPAA Authorizations Subject Eligibility Protocol Compliance (Deviations and Violations) Subject Safety Compliance with the DSMP
9. Sponsored Trials: Exceptions to the Rule Informed Consent Documents and Informed Consent Process Documentation HIPAA Authorizations Subject Eligibility Protocol Compliance (Deviations and Violations) Subject Safety Compliance with the DSMP Expedited
10. Other Resources Toward, J. (2010, November). Contrasting Health Canada and internal academic audit mechanisms and outcomes. SoCRA Source Journal, 66, 26-31. Austin, DM. (2010, November). Investigational product accountability to ensure audit readiness. SoCRA Source Journal, 66, 42-46. Korieth, K. (2011, February). The high cost and questionable impact of 100% SDV: Sponsors, CROs reluctant to alter standard practice. The CenterWatch Monthly, 18(2), pp.1, 15-17.
11. Now It’s Your Turn Answer the questions in Section II (page 2) of your handout to assess the risks inherent in your research group.
12. Where and When is it Audited? Audits are Conducted in the Office/Clinic/Lab Where Study Charts are Stored Audits Fall in the Middle of the Continuing Review Cycle (±2 Months)
13.
14. Where and When is it Audited? Audits are Conducted in the Office/Clinic/Lab Where Study Charts are Stored Audits Fall in the Middle of the Continuing Review Cycle (±2 Months) The Auditor Provides Written Notification to the PI and Lead Study Coordinator Approximately Two Weeks in Advance
15. The Email Notification RE: Internal Audit of Study No. [IRB No.] Dear Dr. [Name]: This email is to remind you that the above-referenced study is scheduled to be audited on [Date]; I will be reviewing the records for all subjects enrolled since the last continuing review approval (Date). I will coordinate the audit with the primary research coordinator on this study, [Name], and will disseminate the findings to the team afterward. Attached to this email are three documents for your reference: A copy of the internal audit template that will be used to direct the audit proceedings; a copy of the General Surgery internal auditing SOP; and a copy of the General Surgery Research Compliance Tip Sheet. If you have any questions about protocol compliance, please feel free to contact me at your convenience. CC: [Research Coordinator]
16. Where and When is it Audited? Audits are Conducted in the Office/Clinic/Lab Where Study Charts are Stored Audits Fall in the Middle of the Continuing Review Cycle (±2 Months) The Auditor Provides Written Notification to the PI and Lead Study Coordinator Approximately Two Weeks in Advance Audits are Scheduled Using Outlook (Appearing on the Research Staff’s Calendar) The PI and Research Staff are Not Present During the Audit The Audit Findings are Disseminated in Writing to the PI, Research Staff, and Regulatory Staff Following the Internal Audit
17. Now It’s Your Turn Answer the questions in Section III (page 2) of your handout to consider the auditing logistics appropriate for your research group.
18. How is it Audited? Informed Consent Documents and Informed Consent Process Documentation HIPAA Authorizations Subject Eligibility Protocol Compliance (Deviations and Violations) Subject Safety Compliance with the DSMP
19. How is it Audited? Proper ICS Version and Pagination Proper IRB Approval Stamp(s) on ICS Proper ICS Execution Informed Consent Process Note Review Proper HIPAA Authorization Version and Pagination Proper IRB Approval Stamp on HIPAA Authorization Proper HIPAA Authorization Execution Medical Records Documentation (VA Only)
20. How is it Audited? Informed Consent Documents and Informed Consent Process Documentation HIPAA Authorizations Subject Eligibility Protocol Compliance (Deviations and Violations) Subject Safety Compliance with the DSMP
21. How is it Audited? Subject Eligibility Eligibility Checklist Review and Source Document Verification (Sampling) Protocol Compliance eCRF Review and Source Document Verification (Sampling)
25. How is it Audited? Subject Eligibility Eligibility Checklist Review and Source Document Verification (Sampling) Protocol Compliance eCRF Review and Source Document Verification (Sampling) Subject Safety eCRF Review and Source Document Verification (Sampling) Regulatory File Review DSMP Compliance Regulatory File Review
26. Now It’s Your Turn Answer the questions in Section IV (page 2) of your handout to consider the internal auditing priorities for your research group.
28. Now It’s Your Turn Answer Question 1 in Section V (page 3) of your handout to brainstorm some “preventative actions” for your research practice.
29. The Coordinator’s Perspective “An ounce of prevention is worth a pound of cure.” Leave a trail of “bread crumbs” for the next person.
30. Now It’s Your Turn Answer Question 2 in Section V (page 3) of your handout to assess how detailed, organized, and reliable you are in your research practice.
31. The Coordinator’s Perspective “An ounce of prevention is worth a pound of cure.” Leave a trail of “bread crumbs” for the next person. Prep for the “big day”.
32. The Coordinator’s Perspective “An ounce of prevention is worth a pound of cure.” Leave a trail of “bread crumbs” for the next person. Prep for the “big day”. Turn that frown upside down.
33. Now It’s Your Turn Answer Question 3 in Section V (page 3) of your handout to identify opportunities to promote internal auditing.