Presentation on theme: "A Blueprint For Clinical Research: Standard Operating Procedures"— Presentation transcript:
1A Blueprint For Clinical Research: Standard Operating Procedures Karen Majchrzak, MS, CCRP
2What 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)
3What are SOPs? 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.
4SOPs are used to: Identify the responsible person for each task. Describe actions (what is to be completed).Train staff.Monitor site performance.
5Are SOPs Required by Law/Regulations? SOPs are not specifically mentioned in the FDA regulationsHOWEVER 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.”
6Are SOPs Required by Law/Regulations? Additionally, SOPs are mentioned repeatedly in the ICH GCP Guidelines.ICH GCP “Systems with procedures that assure the quality of every aspect of the trial should be implemented.”
7Benefits 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.
8Benefits of a SOP? Provides autonomy within the clinical site. Improves the quality of the data collected, thereby improving the science of the study.
9Benefits of a SOP?Utilized as a reference and guideline as to how research will be conducted within the clinical siteExcellent training source for new employees and/or fellows
10SOP Topics Preparing and Submitting Initial IRB Documents Preparing and Submitting Continuing Review IRB DocumentsPreparing and Submitting Amendment IRB DocumentsEstablishing and Training the Clinical Study Team, and Delegating ResponsibilitiesEstablishing Study FilesEstablishing Source Documents
11SOP Topics Study Subject Recruitment Plan Contacting and Scheduling Potential Study Subjects for an Initial VisitObtaining Informed Consent from a Potential Study SubjectEnrolling a SubjectRecording Subject DataMaking Corrections on Study Documents
12SOP Topics Monitoring Subject Compliance During a Study Responding to a Clinical Hold OrderReceiving and Storing Investigational DrugsDrug and Study Supply Transfer Between SitesDispensing Study Drugs to Study SubjectsIdentifying and Reporting Adverse EventsPacking, Labeling, and Shipping SamplesIdentifying and Reporting Protocol Deviations
13SOP Topics Additional Topics Contact with potential sponsors Budget review and determinationsPre-study study site visitInitiation Site VisitMonitor VisitsAuditsData managementStudy closureLong term storage
14Writing SOPsDevelop a template for the SOP to be used throughout the document.Potential elements of the SOPHeader – title, original version date, revision date, effective date, approved byPurpose – why one has the policyResponsibilities – who the policy pertains toInstruction/Procedures – how to accomplish the items of the policyReferences – what the policy is based onAppendix – source documents/case report forms
20Process Mapping for Writing SOPs Determine which clinical site task needs mapping.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.
21Process Mapping for Making a Cup of Coffee Woodin, K. (2004) The CRC’s Guide to Coordinating Clinical Research p CenterwatchPrimary StepEnsure the coffee maker is readyAdd the coffeeAdd the waterTurn on the machineServe the coffee
22Process Mapping for Making a Cup of Coffee Secondary StepEnsure the coffee maker is readyAdd the coffeeAdd the waterTurn on the machineServe the coffeeEnsure the machine is plugged inPlace a filter in the basketUse the carafe to measure the waterWait until the coffee has stopped drippingEnsure carafe is empty and cleanMeasure the coffeePlace the carafe on the heating element
23Process Mapping for Writing SOPs 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.
25SOPs and GuidelinesSome 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.
26SOPs and GuidelinesOne 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.
29Tips for Writing SOPs Use clear, concise language. Use active voice. Avoid names; use titles instead.
30Implementing and Monitoring SOPs SOPs should be introduced gradually.Prioritize most relevant SOPs and present them first.Principle Investigator should approve all SOPs and designate an effective date.
31Implementing and Monitoring SOPs 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.
32SOP Training All staff should have SOP training. Training should be documented.SOP should be accessible to staff.
33What is the difference between a SOP and a Manual of Procedures (MOP)? These terms have been used interchangeably.Both provide a standardization of a process.
34What 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.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.
38MOPThe 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.
39SOP or MOP Both documents are important! 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.
40SOP Resources Examples from National Cancer Institute https://cabig.nci.nih.gov/workspaces/CTMS/Meetings/SIGs/Best_Practices/SOPs/SOPsStandard Operating Procedures for Good Clinical Practice at the Investigative / CenterwatchCost $995 for single site licenseStandard Operating Procedures (SOPs) for Good Clinical Practice / University of WashingtonCost $135