Presentation is loading. Please wait.

Presentation is loading. Please wait.

A Blueprint For Clinical Research: Standard Operating Procedures Karen Majchrzak, MS, CCRP.

Similar presentations


Presentation on theme: "A Blueprint For Clinical Research: Standard Operating Procedures Karen Majchrzak, MS, CCRP."— Presentation transcript:

1 A Blueprint For Clinical Research: Standard Operating Procedures Karen Majchrzak, MS, CCRP

2 What are SOPs? International Conference on Harmonization (ICH) defines a SOP as “Detailed, written instructions to achieve uniformity of the performance of a specific function.” (ICH GCP 1.55) International Conference on Harmonization (ICH) defines a SOP as “Detailed, written instructions to achieve uniformity of the performance of a specific function.” (ICH GCP 1.55)

3 What are SOPs? In simple terms a SOP is… In simple terms a SOP is… –A written process –A way for the clinical site to perform a task the same way each time it is completed.

4 SOPs are used to: Identify the responsible person for each task. Identify the responsible person for each task. Describe actions (what is to be completed). Describe actions (what is to be completed). Train staff. Train staff. Monitor site performance. Monitor site performance.

5 Are SOPs Required by Law/Regulations? SOPs are not specifically mentioned in the FDA regulations SOPs are not specifically mentioned in the FDA regulations –HOWEVER there is guidance and regulations that infer responsibility and SOPs formalize investigator responsibilities. –21 CFR the investigator will “ensure that all associates, colleagues, and employees assisting in the conduct of the study (ies) are informed of their obligations in meeting the above commitments.”

6 Are SOPs Required by Law/Regulations? Additionally, SOPs are mentioned repeatedly in the ICH GCP Guidelines. Additionally, SOPs are mentioned repeatedly in the ICH GCP Guidelines. ICH GCP “ ICH GCP “Systems with procedures that assure the quality of every aspect of the trial should be implemented.”

7 Benefits of a SOP? Ensures that all research conducted within the clinical site follows federal regulations, ICH GCP, and institutional policies to protect the rights and welfare of human study participants. Ensures that all research conducted within the clinical site follows federal regulations, ICH GCP, and institutional policies to protect the rights and welfare of human study participants.

8 Benefits of a SOP? Provides autonomy within the clinical site. Provides autonomy within the clinical site. Improves the quality of the data collected, thereby improving the science of the study. Improves the quality of the data collected, thereby improving the science of the study.

9 Benefits of a SOP? Utilized as a reference and guideline as to how research will be conducted within the clinical site Utilized as a reference and guideline as to how research will be conducted within the clinical site Excellent training source for new employees and/or fellows Excellent training source for new employees and/or fellows

10 SOP Topics Preparing and Submitting Initial IRB Documents Preparing and Submitting Initial IRB Documents Preparing and Submitting Continuing Review IRB Documents Preparing and Submitting Continuing Review IRB Documents Preparing and Submitting Amendment IRB Documents Preparing and Submitting Amendment IRB Documents Establishing and Training the Clinical Study Team, and Delegating Responsibilities Establishing and Training the Clinical Study Team, and Delegating Responsibilities Establishing Study Files Establishing Study Files Establishing Source Documents Establishing Source Documents

11 SOP Topics Study Subject Recruitment Plan Study Subject Recruitment Plan Contacting and Scheduling Potential Study Subjects for an Initial Visit Contacting and Scheduling Potential Study Subjects for an Initial Visit Obtaining Informed Consent from a Potential Study Subject Obtaining Informed Consent from a Potential Study Subject Enrolling a Subject Enrolling a Subject Recording Subject Data Recording Subject Data Making Corrections on Study Documents Making Corrections on Study Documents

12 SOP Topics Monitoring Subject Compliance During a Study Monitoring Subject Compliance During a Study Responding to a Clinical Hold Order Responding to a Clinical Hold Order Receiving and Storing Investigational Drugs Receiving and Storing Investigational Drugs Drug and Study Supply Transfer Between Sites Drug and Study Supply Transfer Between Sites Dispensing Study Drugs to Study Subjects Dispensing Study Drugs to Study Subjects Identifying and Reporting Adverse Events Identifying and Reporting Adverse Events Packing, Labeling, and Shipping Samples Packing, Labeling, and Shipping Samples Identifying and Reporting Protocol Deviations Identifying and Reporting Protocol Deviations

13 SOP Topics Additional Topics Contact with potential sponsors Contact with potential sponsors Budget review and determinations Budget review and determinations Pre-study study site visit Pre-study study site visit Initiation Site Visit Initiation Site Visit Monitor Visits Monitor Visits Audits Audits Data management Data management Study closure Study closure Long term storage Long term storage

14 Writing SOPs Develop a template for the SOP to be used throughout the document. Develop a template for the SOP to be used throughout the document. Potential elements of the SOP Potential elements of the SOP –Header – title, original version date, revision date, effective date, approved by –Purpose – why one has the policy –Responsibilities – who the policy pertains to –Instruction/Procedures – how to accomplish the items of the policy –References – what the policy is based on –Appendix – source documents/case report forms

15

16

17

18

19

20 Process Mapping for Writing SOPs Determine which clinical site task needs mapping. Determine which clinical site task needs mapping. Lay out all the steps currently used to complete that task. Lay out all the steps currently used to complete that task. “Mapping” involves taking each step in the task and making it more efficient and easier to follow. “Mapping” involves taking each step in the task and making it more efficient and easier to follow.

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

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

23 Process Mapping for Writing SOPs Once you have finished mapping, convert your process map to an outline for easy use. Once you have finished mapping, convert your process map to an outline for easy use. Once a task has been mapped, it should be tested. Once a task has been mapped, it should be tested.

24

25 SOPs and Guidelines Some SOPs have a two-tiered system that includes both SOPs and guidelines. Some SOPs have a two-tiered system that includes both SOPs and guidelines. SOPs provide a general view of all the main steps whereas guidelines are significantly more detailed. SOPs provide a general view of all the main steps whereas guidelines are significantly more detailed.

26 SOPs and Guidelines One advantage of a two-tiered system is that SOPs will rarely need to be changed, whereas guidelines may need to be changed or updated more frequently due to changes in organizational structure or equipment. One advantage of a two-tiered system is that SOPs will rarely need to be changed, whereas guidelines may need to be changed or updated more frequently due to changes in organizational structure or equipment.

27

28

29 Tips for Writing SOPs Use clear, concise language. Use clear, concise language. Use active voice. Use active voice. Avoid names; use titles instead. Avoid names; use titles instead.

30 Implementing and Monitoring SOPs SOPs should be introduced gradually. SOPs should be introduced gradually. Prioritize most relevant SOPs and present them first. Prioritize most relevant SOPs and present them first. Principle Investigator should approve all SOPs and designate an effective date. Principle Investigator should approve all SOPs and designate an effective date.

31 Implementing and Monitoring SOPs SOPs should be reviewed on a regular basis (usually annually) to ensure policy based regulations are up-to- date. SOPs should be reviewed on a regular basis (usually annually) to ensure policy based regulations are up-to- date. Previous versions of SOPs should be retained. Previous versions of SOPs should be retained.

32 SOP Training All staff should have SOP training. All staff should have SOP training. Training should be documented. Training should be documented. SOP should be accessible to staff. SOP should be accessible to staff.

33 What is the difference between a SOP and a Manual of Procedures (MOP)? These terms have been used interchangeably. These terms have been used interchangeably. Both provide a standardization of a process. Both provide a standardization of a process.

34 What is the difference between a SOP and a Manual of Procedures (MOP)? SOP provides general information that is to be utilized throughout any research study. SOP provides general information that is to be utilized throughout any research study. –How as a clinical site we will assess delegation of duties. MOP is specifically written for a particular research study which will incorporate elements of the SOP. MOP is specifically written for a particular research study which will incorporate elements of the SOP.

35

36

37

38 MOP The MOP should be written so that anyone in your clinical site can follow the procedures for that study and find all relevant materials. The MOP should be written so that anyone in your clinical site can follow the procedures for that study and find all relevant materials. The MOP should be extremely detailed. The MOP should be extremely detailed.

39 SOP or MOP Both documents are important! Both documents are important! Start with the SOP first. Once you have written general procedures, the MOP will be easier. Start with the SOP first. Once you have written general procedures, the MOP will be easier. This process will take lots of time and patience. This process will take lots of time and patience.

40 SOP Resources Examples from National Cancer Institute Examples from National Cancer Institute https://cabig.nci.nih.gov/workspaces/CTMS/Meetings/SIGs/Be st_Practices/SOPs/SOPs https://cabig.nci.nih.gov/workspaces/CTMS/Meetings/SIGs/Be st_Practices/SOPs/SOPs Standard Operating Procedures for Good Clinical Practice at the Investigative / Centerwatch Standard Operating Procedures for Good Clinical Practice at the Investigative / Centerwatch Cost $995 for single site license Standard Operating Procedures (SOPs) for Good Clinical Practice / University of Washington Standard Operating Procedures (SOPs) for Good Clinical Practice / University of Washington spx spx Cost $135

41 Comments and Questions?


Download ppt "A Blueprint For Clinical Research: Standard Operating Procedures Karen Majchrzak, MS, CCRP."

Similar presentations


Ads by Google