Policies, SOPs, MOPs, Protocols

Transcription

1 PREP Course #6: Policies, SOPs, MOPs, Protocols OH MY! Presented by: Tina Chuck, MPH Manager, Research Policy and Training Research Administration North Shore-LIJ Health System Phone: Cerdi Beltré, CIP, CCRC Administrative Director, Clinical Research Service Director, Clinical Research Operations, NSLIJHS The Feinstein Institute for Medical Research North Shore-LIJ Health System Phone:

2 CME Disclosure Statement The North Shore LIJ Health System adheres to the ACCME s new Standards for Commercial Support. Any individuals in a position to control the content of a CME activity, including faculty, planners, and managers, are required to disclose all financial relationships with commercial interests. All identified potential conflicts of interest are thoroughly vetted by the North Shore-LIJ for fair balance and scientific objectivity and to ensure appropriateness of patient care recommendations. Course Director and Course Planner, Kevin Tracey, MD and Tina Chuck, MPH have nothing to disclose. Tina Chuck, MPH and Cerdi Beltré, CIP, CCRC are the speakers and have nothing to disclose.

3 Class Objectives At the end of today s class you should be able to: 1) Recognize the differences between policies, SOPs, MOPs, and protocols. 2) Explain the usefulness of policies, SOPs, MOPs, and protocols. 3) Demonstrate how to search for health system policy on HealthPort. 4) Apply process mapping when writing SOPs. SOPs Policies Protocols MOPs

4 POLICY Health System; Facility/Department specific STANDARD OPERATING PROCEDURES (SOP) PROTOCOL 1 Protocol per Research Project MANUAL OF OPERATIONS (MOP) 1 MOP per Protocol DEFINITION What is it and how are they different? A predetermined course of action established as a guide toward accepted business strategies and objectives. It can be proposed by a government, party, business, or individual. Detailed, written instructions to achieve uniformity of the performance of a specific function. (ICH GCP 1.55) In simple terms: A written process by which a task can be performed the same way each time. It provides instructions necessary to carry out a policy. A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. (ICH GCP 1.44) A handbook of instructions designed to guide the research team to successfully carry out aspects of a research project according to research protocol. Clinical trial site specific and applicable across protocols

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6 POLICY STANDARD OPERATING PROCEDURES (SOPs) PROTOCOL MANUAL OF OPERATIONS (MOPs) Benefits Why should I care? Set boundary conditions so that actions and decisions are made consistently in pursuit of an objective; create expectations and guides for actions. Allows management and employees to operate without constant intervention. Reflect the vision/mission of the organization. Provides standardization of processes across protocols at a clinical trial site. Manage compliance obligations Incorporates regulations, GCPs, and institutional policies. Create operational efficiency Ensures processes have been examined and optimized. Training staff Acts as a resource to keep everyone on the same page at all times. Is a road map for the research project. Clearly spells out why you are doing the research, what the research question and data needed to answer the question are, and how to gather and analyze the data. Provides standardization of processes for one particular research protocol. Clearly spells out the who, what, where, when, and how. Training staff Acts as a resource to keep everyone on the same page at all times. Particularly helpful when someone is covering for another due to vacation, sick time, staff turnover, etc.

7 What is the Policy Statement? One-third of all staff must be rated as does not meet expectations. Why SOPs? In this case, without SOPs there would be no standardized written process to detail how this decision is made each time to meet the policy requirements.

8 Case Studies of Human Subjects Research According to Policies, SOPs, Protocol, and MOPs

9 Example 1: Consent POLICY TITLE: Policy GR089 Informed Consent and Recruitment for Human Subject Research SOPs: Informed Consent SOP# 7 Adult and Peds PROTOCOL MANUAL OF OPERATION (MOP) The PI approved by the IRB If greater than minimal risk then investigator will be a Responsible Practitioner defined in NSLIJHS Policy # (Informed Consent and Medical Decision Making for Patients Who Lack Capacity) The CRC or Investigator discusses the informed consent form with the potential study subject If a minor turns 18 during their participation in a study, they will be consented as an adult. Specify how this is done, ex.: For applicable studies, Outlook calendar will be flagged with the birth date of subject which will trigger one month prior. Speak with subject in person or contact the subject via phone, and/or letter to invite/schedule the consent visit. If multiple attempts fail, withdraw the subject as lost to follow-up. One parental signature is required Adults provide consent form self None provided for this protocol. 45 CFR : investigator obtains the legally effective informed consent of the subject or the subject's legally authorized representative.

10 Example 2: Investigative Product POLICY TITLE: Policy GR049 Medications and Investigational New Drugs PI: Ensures that resources necessary to conduct a clinical investigation are available at the designated Department of Pharmacy PRIOR to the study initiation Provides essential documentation for the dispensation of investigational drug(s) THROUGHOUT the study. SOPs: TEST ARTICLE MANAGEMENT SOP# 10 PI: Provides appropriate personnel/department of Pharmacy, with a copy of the approved protocols, consent documents, plus any additional information such as amendments, changes in investigator(s) Maintains secure test article records Administered by individuals that are IRB approved to do so, and at least one of the following Diabetes XYZ PROTOCOL 75 mg TID with food MANUAL OF OPERATION (MOP) Each pill is 25 mg = dispense 3 pills three times daily for the 30 day dosing period. Stored in tightly closed containers and protected from moisture and excessive heat. Room temperature; 15 to 30 C (59 TO 86 F). Locked cabinet in a secure area of the clinical research center or research pharmacy. The research pharmacist/nurse may assume responsibility for drug accountability. GCP E6: The sponsor should determine for the IP, the acceptable storage temperatures, storage conditions and procedures. The sponsor should inform all involved parties of these determinations The investigator should qualified staff and adequate facilities to conduct the trial properly and safely.

11 Example 3: Labs POLICY TITLE: Policy GR080 Human Subject Research Oversight and Monitoring SOPs: Processing of Specimens SOP# 17 Lupus XYZ PROTOCOL MANUAL OF OPERATION (MOP) Comply with ICH E6: Good Clinical Practice (GCP) PI is responsible for complying with protocol Follow the lab manual Follow health system policy Review the protocolspecific laboratory manual Baseline Tests Performed: Chemistry Hematology 24 hr. urine PT, PTT w/inr Ask for clarification before performing the required procedure when information is unclear. Sterile processing Infection control Etc. GCP E6: 6.7 Protocol should specify efficacy parameters, timing for assessing, recording, and analyzing efficacy parameters.

12 Development and Implementation of POLICIES Federal Regulations, Industry Guidance, best practices, etc. Other Policies (i.e. Facility Policies, Departmental Policies) Health System Policies Examples include HS Corporate Compliance policies, HS Human Resources policies, HS OCIO policies, HS Infection Control policies, and HS Research policies.

13 Development and Implementation of NSLIJ Health System Research Policies Governed by health system policy Developing and Revising NSLIJ Health System Administrative Policies and Procedures.

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15 Development of Health System Research Policies Step 1 Step 2 Step 3 Step 4 Step 5 Draft new policy or revisions to existing policy with policy owner(s) and content experts. 1. Policy Development can take months a lot of thought is put into writing policy by content experts, including those who would be affected by the policy in their day to day tasks. Submit to System Administrative Policy and Procedure Committee (System P&P) and Feinstein Policy and Procedure Committee (Feinstein P&P) for 3 rounds of review. After System P&P approval, submit to System Performance and Improvement Coordinating Group/Clinical Operation Committee (System PICG). 2. Policies are not stagnant; they can change due to After changes System PICG approval, in federal submit regulations, to Feinstein P&P to vote new on adoption of finalized policy if they are applicable to research staff. processes, etc. Changes are limited to what is needed and necessary. Adopted health system research policies are communicated to employees via , trainings, Research Matters newsletter, posted on HealthPort, at meetings, and at the departmental level.

16 Where do you find NSLIJ Health System Policies? Each facility will be listed as you scroll down

17 Development and Implementation of Standard Operating Procedures (SOPs) Governed by: Health system research policy GR095 Requirements of Standard Operating Procedures for Clinical Trial Sites, and A Standard Operating Procedure for maintaining and writing SOPs

18 What does our health system research policy on SOPs say? GR095 Policy Statement: All clinical trial sites conducting clinical trials at or on behalf of the health system must have SOPs as outlined herein. 15 SOPs required for all clinical trial sites; additional 3 required, if applicable. A clinical trial site is defined as the location where clinical research (research involving investigational products such as drugs or devices) is taking place. This can be a site, department, facility, or equivalent.

19 Who is responsible for SOPs at the clinical trial sites? Per Policy GR095: Departmental or Unit leadership, in collaboration with their Principal Investigators (PIs), or designee(s), are responsible for writing, implementing, maintaining, and ensuring compliance with clinical trial SOPs at their clinical trial site(s). TIP: The best person to write what you do is the person who does it!

20 Writing SOPs 1) Develop a template to be used for all SOPs. NOTE: The Clinical Research Service (CRS) provides templates for the different required SOPs on their website. Templates should be modified accordingly to meet your site s needs. If you choose to develop your own template, be sure to include the required elements that are listed in policy GR095 (i.e. objectives, responsibilities, procedures, etc.). 2) Select topics that SOPs will be created for. NOTE: Per health system policy GR095, clinical trial sites are required, but not limited, to have the 15 SOPs that are noted in the policy; and an additional 3 SOPs, if applicable. Non-clinical trial sites are encouraged to have SOPs, but are not required.

21 Process Mapping for Writing SOPs 1) Focus on 1 SOP at a time; 1 process for 1 SOP. i.e. Informed Consent, Disaster Plan, Study Close-Out 2) Write down all the steps currently used to complete the process for that SOP. Example of steps used in informed consent: Step 1: Obtain the consent form. Step 2: Verify that you are using the most current IRB-approved version. Step 3: Provide a copy of the consent form to the subject/representative. 3) Mapping involves taking each step in the process and making it more efficient and easier to follow.

22 Process Mapping for Making a Cup of Coffee Woodin, K. (2004) The CRC s Guide to Coordinating Clinical Research p Centerwatch Primary Step Ensure the coffee maker is ready Add the coffee Add the water Turn on the machine Serve the coffee

23 Process Mapping for Making a Cup of Coffee Secondary Step Ensure the coffee maker is ready Add the coffee Add the water Turn on the machine Serve the coffee Ensure the machine is plugged in Place a filter in the basket Use the carafe to measure the water Wait until the coffee has stopped dripping Ensure carafe is empty and clean Measure the coffee Place the carafe on the heating element

24 Process Mapping for Writing SOPs Process mapping should include input from people involved in all the steps; they are the content experts. Processes should be tested for best practices. Translate the process map into your SOP template. Worksheets, flowcharts, forms, and checklists can be incorporated into your SOPs.

25 Tips for Writing SOPs Use clear, concise language. Use active voice. Avoid names; use titles instead. Write SOPs in the way that would work for your clinical trial site. For example, you can have SOPs that are only applicable to coordinators, or only applicable to investigators, or only applicable to Principle Investigators.

26 Implementing and Monitoring SOPs What does Policy GR095 say? Implementation/Education All SOPs must be designated an effective date. Documentation of approval must be obtained with appropriate dated signatures. All applicable staff should receive education for new and revised SOPs; education must be documented. SOPs must be accessible to staff in a centralized location, either electronically or via paper copy. Revisions/Archiving SOPs must be reviewed on a regular basis (usually every 2 years at a minimum) for possible revisions due to changes in regulations or site procedures. Previous versions of SOPs must be retained in a centralized location accessible to staff, either electronically or via paper copy. In the event of a regulatory audit, the auditor may audit a study against the SOP that was in effect at the time of study conduct.

27 Tips for Implementing and Monitoring SOPs Introduce SOPs gradually so that staff do not become overwhelmed. Prioritize most relevant SOPs and present them first. Revise SOPs on a regular basis due to changes in process, regulations, and policies.

28 Educating/Training Staff on SOPs Applicable staff should have SOP training. Best to have the author(s) train team members on the SOP. Education/training must be documented. SOP should be easily accessible to staff.

29 Q: Where can you find NSLIJ Clinical Trial Site SOP Templates? A:

30 Standard Operating Procedures Required Standard Operating Procedures for SOPs Coordinator Qualification, Responsibilities and Training Investigator Qualification, Responsibilities and Training Departmental Assessment of Protocol Feasibility Data Management and Documentation Recruitment and Retention of Subjects Informed Consent Required, Cont. Resolving and Reporting Protocol Deviations, Violations, AE/SAEs, Unanticipated Problems, and Documentation Sponsor Interactions Test Article Management Quality Control & Assurance Study Close-Out Study Confidentiality and Security Disaster Plan Patient Complaint Process As needed Point of Care Laboratory Testing Processing of Specimens Safety

31 Differentiating NSLIJHS in Clinical Research Operations 1) Experienced staff 1 5 2) Established procedures ) Access to large #s of patients 4) Mature CT infrastructure 5) Investigators who practice in settings relevant to the questions being asked 6) Performance 7) Quality 8) Nimble? Bullets 1-5 from Institute of Medicine (IOM) discussion paper: Developing a Clinical Trials Infrastructure in the United States, May BMW M3 V8 Engine

32 Questions For general questions regarding SOPs and clinical research operations, contact: Cerdi Beltré, CIP, CCRC Administrative Director, Clinical Research Service The Feinstein Institute for Medical Research North Shore-LIJ Health System Phone: For general questions regarding policies, contact: Tina Chuck, MPH Manager, Research Policy and Training Research Administration North Shore-LIJ Health System Phone: