Fairplay Consultants, Inc. - Writing SOPs for the Investigator Site

Writing SOPs for the Investigator Site

Description:

This course will provide a SOP template, associated documents, and cover the mechanics of getting your site SOPs up and running.

Overview:

Standard Operating Procedures (SOPS) are expected at the study site. Just ask sponsor companies, regulatory agencies, and anyone else doing global clinical trial research according to GCPs, today. This course will aid the study site staff in understanding the need for SOPs, explain how to begin the SOP documentation process, show how to actually write a concise SOP, explain the training obligations, and clarify the associated attachments that go along with the mapping of site processes. We will create one SOP that you can use at your study site.

Who Should Attend:

STAFF FROM ANY AND ALL SITES THAT ARE CURRENTLY SOP-LESS! Don't delay, sign up.

Objectives:

The participant will:

understand the need for SOPs at the study site

create a SOP according to a template structure

recognize the regulations, guidances, and predicate rules that support the SOP

understand the SOP approval, tracking, and modification processes

demonstrate the ability to effectively describe site processes in the SOP

identify acceptable adult training programs and documentation methods

Agenda:

Two great learning sessions comprise this one-day workshop: the morning session from 10am-1pm and the afternoon session from 2pm-5pm. Take lunch on-your-own at the New Panda Chinese Restaurant or Spankys Grill (just a 3 minute walk).

Questions we will address during the workshop:

What is an SOP?

Why do we need SOPs?

How do we begin to develop SOPs at our site?

What are the sections of the SOP?

Is there a particular format we must follow, or can we make a template that suits our particular site needs?

Where do we find the regulations, guidelines, and predicate rules?

Do we only address FDA or should we consider ICH, EU, other regulatory agencies?

When do the SOPs take effect?

What is the approval process?

How can we make sure we're all working from the same SOP version?

Can we change SOPs once they've been adopted?

Who trains the staff - with what training program - metrics - how do we fund it?

Where do I keep my training on SOP file?

Will I get more training when the SOPs change?

Are there industry case studies/stories that demonstrate the need for SOPs?

Please note:

If you would like to see this course offered in your area, please contact us for scheduling opportunities and fees.

For further training in this subject area, please consider:

Clinical Research 101

Notes:

These two study site courses help the study site better understand the business aspects and the clinical trial aspects of research. It is important to get things right before the sponsor (or FDA) audit. We encourage advance planning -- this course will help you create your MUST DO checklist. As we all know, Quality Assurance (QA) starts at the beginning with good planning. This Clinical Research 101 course will help you understand the big picture of drug development, the study site role, and critical business planning before you get started.