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SMT Overview S T U D Y

M A N A G E M E N T

T E A M

Learn about the Study Management Team and be ready for your first meeting!

collaborate.gilead.com/md/ClinOps


TABLE OF CONTENTS

1.

Overview

04

Membership

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Role Overview

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4.

SMT Formation & Disband-

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5.

ClinOps Roles & Responsibilities

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6.

Best Practices

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7.

Special Situations

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8.

Key Takeaways

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9.

Next Steps

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2. 3.


CHAPTER 1

YOU WILL LEARN

After completing this flipbook you will: Understand the role and purpose of the SMT in study management.

What Will Yo u L e a r n a b o u t To d a y ?

Identify cross-functional collaborators and their contributions to the SMT.

Understand expectations associated with your role on the SMT.


BASICS Let’s start with a recap of what the SMT is: A cross-functional team responsible for effective start-up, conduct, execution and delivery of clinical trial(s) in line with the Project Team and Clinical Sub-Team plans.

It’s main purpose is study management: Ensure strategic and tactical implementation of the study plan

Decision-making for key/critical issues

Maintains Open Lines of Communication and effective information flow between functional area leadership, Project team, and Sub-Teams (as applicable)

Generate solutions to arising issues

Risk Identification and mitigation during the course of the study

Update plans and timelines as necessary

REDOING GRAPHIC

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REDOING GRAPHIC CHAPTER 2

ROLE & MEMBERSHIP

Role and Membership


Clinical Operations leads the SMT.

MEMBERS INCLUDE: Clinical Research

Regulatory Affairs

Biometrics

Project Management

Clinical Supply Management

Clinical Pharmacology

Clinical Contracts & Finance / Vendor Project Manager / Contracts / Payments

Pharmacovigilance & Epidemiology

Virology / Biomarkers etc.

Vendor (Typically the CRO Project Manager)

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CHAPTER 3

ROLE OVERVIEW

Role Overview

As the ClinOps representative leading the SMT, here is how our other members contribute to the SMT.


ROLE

OVERVIEW SMT members make various contributions to study management, depending on the stage of the study. The next few pages outline some of these contributions.

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CHAPTER 3 ROLE OVERVIEW cont.

Clinical Research Clinical research brings medical expertise and clinical rationale to the protocol and SMT. Can also offer insight into who the key opinion leaders are in the therapeutic area in various regions.


Biometrics We have a few different groups under our umbrella, some of which include data management, clinical programming and biostatistics. You’ll need our input in all aspects of analysis. We also identify trends in the data throughout the course of the study. We’ll continue to keep the team informed about protocol adherence and issues through analyzing the data on a regular basis.

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CHAPTER 3 ROLE OVERVIEW cont.

Clinical Supply Management (CSM) As your CSM representative, we provide you with drug forecasting throughout the course of your study based on your enrollment forecast as well as help provide guidance on shipping drug to regions all around the globe. We can also help with any issue resolution surrounding drug such as quality and/or supply issues.


Regulatory Affairs We only attend SMT on an ad-hoc basis, however, regulatory can have a large role to play throughout the course of the study, whether it is regarding IB, ICF or Protocol approval for a country or perhaps guidance on specific regional approvals.

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CHAPTER 3 ROLE OVERVIEW cont.

Clinical Supply Management (CSM) As your CSM representative, we provide you with drug forecasting throughout the course of your study based on your enrollment forecast as well as help provide guidance on shipping drug to regions all around the globe. We can also help with any issue resolution surrounding drug such as quality and/or supply issues.


Regulatory Affairs We only attend SMT on an ad-hoc basis, however, regulatory can have a large role to play throughout the course of the study, whether it is regarding IB, ICF or Protocol approval for a country or perhaps guidance on specific regional approvals.

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CHAPTER 3 ROLE OVERVIEW cont.

Project Management Throughout the course of the study, we will work together to ensure project timelines are on track and discuss any potential risks and how they could possibly put the product timeline at risk.

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Clinical Pharmacology If your study has PK samples, we will be more than happy to help establish what is needed in the protocol in alignment with the clinical objectives. (i.e. will inform if we have enough samples, if samples are sufficient, etc.)

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CHAPTER 3 ROLE OVERVIEW cont.

Pharmacovigilance & Epidemiology (PVE) Also referred to as the Safety group, we partner with the study team and sites to identify and communicate all and any safety reporting. Everything from serious adverse events to unrelated events should be reported to safety. This should be done through RAVE or, in the event of an emergency - SAE forms can be faxed into PVE.


Vendor Project Manager As one of the many roles within CCF, I can help provide guidance and relationship management with any of our many vendors. Issues that arise can be brought up at SMT, documented in the vendor issue tracker and/or can be escalated accordingly

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CHAPTER 3 ROLE OVERVIEW cont.

Biomarkers We will partner with you and your clinical scientist to determine if biomarker testing is needed, and if so establish the goals and objectives for the trial to meet the biomarker target. We can also be instrumental in lab manual development. Throughout the course of the study, we’ll continue to check in to assess biomarker testing needs and help with sample management, analysis, and data transfer.


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CHAPTER 3 ROLE OVERVIEW cont.

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CLINICAL

OPERATIONS As you may already know, Clinical operations leads the SMT and drives the study through collaborating with cross functional counterparts to ensure that the study deliverables are met on time and within budget.


Our group is responsible for the management and oversight of all operational aspects of clinical trials. CTM Roles include: CTM Leadership, Program Management, Study Management and Study Assistance. We’ll explore roles in further detail a little later.

We’ll explore roles in further detail on the next few pages.

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CHAPTER 4

CLINICAL ROLES

CLINICAL

ROLES & RESPONSIBILITIES Responsibilities within the SMT depend on your role within Clinical Operations.

Clinical Roles & Responsibilities

Let’s take a look at the roles of the people responsible for the management of Gilead’s clinical studies, beginning at the top with Clinical Trials Management Leadership. This group makes key decisions critical to the Company’s long and shortterm business goals. The scope for leadership responsibilities grow from the various roles from Assoc Director → Director → Senior Director → VP.


CTM Leadership

Program

Manage-

Study Management

Study Assistance

Sr. CTM/CTM

Sr. CPM

CTMA

CPA

Responsible for the day-today operations of leading the study

Provides oversight and strategic direction across many projects

Responsible for managing assigned vendors and/or regions

Providing Study Support

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CHAPTER 4

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CLINICAL ROLES cont.

CTM Leadership Sr. CTM/CTM Responsible for the day-today operations of leading the study


CTM LEADERSHIP More on CTMAs: The degree of responsibility between each CTMA will vary significantly. For example, some CTMAs will support 3-4 studies, but will have a 4-5 person team that will assist with managing different vendors and/or regions; other CTMAs may lead a study on their own. It will depend on study design, phase, and resourcing.

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CHAPTER 4 CLINICAL ROLES cont.

Program Management Sr. CPM Provides oversight and strategic direction across many projects


PROGRAM MANAGEMENT The Clinical Program Manager/Sr. CPM provides oversight and strategic direction across many projects. They’re responsible for study milestones and budgets and they provide guidance to the study management team.

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CHAPTER 4 CLINICAL ROLES cont.

Study Management CTMA Responsible for managing assigned vendors and/or regions


STUDY MANAGEMENT The Study Management group manages study responsibilities assigned by their program manager. The level of responsibility will vary, but they may work on the protocol, ICF development, managing vendors, on-site monitoring or CRO management. This group may take on CPM duties depending on trial, number of CTMs/CTMAs on study. If an individual has a desire for a management career track, the SCTM role is a transitional position (next step is CPM). Roles progress from Clinical Trials Management Associate → Senior CTMA→ Clinical Trials Manager → Senior CTM. Note: CRO monitors do the majority of the fieldbased monitoring.

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CHAPTER 4 CLINICAL ROLES cont.

Study Assistance CPA Providing Study Support


STUDY ASSISTANCE Supports multiple clinical studies, clinical supplies, study documents, and database maintenance provides administrative and study support surrounding study docs/databases, assistance with study supplies/IMP shipment, etc. Roles include Clinical Project Assistant (CPA).

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CHAPTER 5

SMT FORMATION& DISBANDING

SMT FORMATION & DISBANDING The SMT forms when a study is approved by PST and CST.

SMT Formation & Disbanding


SMT Disbanding The SMT continues throughout the study, and disbands when the Examples of some of the documents that may be produced through the SMT include, but are definitely not limited to SMT Charter, SMT meeting minutes, SMT Decision Log

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is this part of Chapter 5?

RACI Guide A RACI guide is available that outlines the person Responsible, Accountable, to be Consulted, and to be Informed within Clinical Operations. Access this resource here: __________


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Chapter Six

Best Practices

Chapter Seven Special Situations Chapter Eight Key Takeaways Chapter Nine Next Steps


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SMT OVERVIEW  

Learn about the Study Management Team and be ready for your first meeting!

SMT OVERVIEW  

Learn about the Study Management Team and be ready for your first meeting!

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