SOPS

MedDRA
A standardized dictionary of medical terminology ICH initiative Objective To share regulatory information internationally about medical products used by humans.

MedDRA : Use

To share information regarding Medical product registration Documentation Safety monitoring

Before and after approval for sell.

MedDRA : Basis
1. 2. 3. 4. UK Medicines Control Agency's (MCA) medical terminology. World Health Organization Adverse Reaction Terminology (WHO-ART) International Classification of Diseases with Clinical Modification (ICDCM) 5. 6. Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART) Japanese Adverse Reaction Terminology (J-ART)

MedDRA : Contents
MedDRA includes terminology for Symptoms

Signs
Diseases Diagnoses

Investigations
Sites Therapeutic indications Surgical and medical procedures Medical, social and family history terms

MedDRA : Functioning
Maintained by The MedDRA Maintenance and Support Services Organization (MSSO)

Used by Therapeutic Products Directorate (Canada) Food and Drug Administration (US) Pharmaceutical and biological manufacturers

Several major regulatory authorities

Common Technical Document

MedDRA : Role
Consistency at international level Easy comparisons

Decreased the loss or distortion of information

Improved effectiveness of medical product regulation worldwide

Standard Operating Procedures

SOPs are used to

Identify the responsible person for each task. Describe actions (what is to be completed).

Train staff.
Monitor site performance.

The Main Objective

Be a GREAT clinical research site For the sponsor For your patients For your organization For your own professional development

What are SOPs?

Standard Operating Procedures (SOP) are: a set of instructions with the force of a directive that defines or standardizes a procedure or specific function

an effective catalyst to drive performance improvement and improve

organizational results create the level of quality and accepted practice for a specific procedure the foundation of every good quality system

SOPs for Clinical Research

Clinical research SOPs are an important way to help you follow Good Clinical Practices (GCPs)

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)

SOPs and 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 CFR312.53 mandates that the investigator will ensure that all associates, colleagues, and employees assisting in the conduct of the study are informed of their obligations in meeting the above

commitments.

SOPs and Regulations

Additionally, SOPs are mentioned repeatedly in the ICH GCP Guidelines. ICH GCP 2.13 -Systems with procedures that assure the quality of every aspect of the trial should be implemented.

Benefits of SOPs
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

Improves the quality of the data collected, thereby improving the science

of the study.
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

Key Components of SOPs Description of the purpose of the procedure/task

Background information and definitions

Specific components to successfully perform the

task/procedure
Required personnel to perform all aspects of the

procedure
Appropriate patient population (as applicable)

Required equipment, supplies, information and/or data

 Equipment settings, as appropriate and/or necessary to acquire/process data Quality control procedures to assure optimal results Interpretation and reporting criteria, as necessary for consistent and uniform review of data Effective date and expiration date

SOPs: An Educational Tool

SOPs may be used as an educational tool to: Familiarize the entire research team on the specific tasks performed

by the departments participating in the research protocol

Educate the drug company/investigator on regulatory guidelines

and SOPs already in place for departments such as radiology,

nuclear medicine and radiation therapy in the performance of dayto-day procedures Train current and new employees to assure consistent performance of the research protocol

SOP Topics
Preparing and Submitting Initial IRB Documents

Preparing and Submitting Continuing Review IRB

Documents

Preparing and Submitting Amendment IRB Documents

Establishing and Training the Clinical Study Team, and

delegating Responsibilities
Establishing Study Files

Establishing Source Documents

 Study Subject Recruitment Plan Contacting and Scheduling Potential Study Subjects for an Initial Visit Obtaining Informed Consent from a Potential Study Subject

Enrolling a Subject
Recording Subject Data Making Corrections on Study Documents

 Monitoring Subject Compliance During a Study Responding to a Clinical Hold Order

Receiving and Storing Investigational Drugs

Drug and Study Supply Transfer Between Sites Dispensing Study Drugs to Study Subjects Identifying and Reporting Adverse Events Packing, Labeling, and Shipping Samples Identifying and Reporting Protocol Deviations

Additional Topics
Contact with potential sponsors Budget review and determinations Pre-study study site visit Initiation Site Visit

Monitor Visits
Audits Data management Study closure Long term storage

Writing SOPs
Develop a template for the SOP to be used throughout the document. 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

Process 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.

Example

Process Mapping for Making a Cup of Coffee

Primary Step
Ensure the coffee maker is ready Add the coffee Add the water Turn on the machine Serve the coffee

Secondary Step

Ensure the coffee maker is ready Ensure the machine is plugged in Ensure carafe is empty and clean

Add the coffee Place a filter in the basket Measure the coffee

Add the water Use the carafe to measure the water Place the carafe on the heating element

Turn on the machine

Serve the coffee

Wait until the coffee has stopped dripping

Implementing 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.

Implementing 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.

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