Standards, Tasks And Responsibilities Matrix

The Use of a STAR Matrix in Clinical Project Management

Introduction

Even the smallest clinical trials are often organisationally complex because of the number of companies that are involved. In 2004 it was not unusual, even in Phase 1, to find a trial where the Sponsor undertakes one or two tasks and the remainder are contracted to 4 or 5 different organisations. In larger, multi-site trials, there can also be several organisations undertaking a single task (for example, investigator-site management and monitoring).

This situation can present challenges for the Sponsor and the trial's Project Manager, in ensuring GCP compliance, adequate consistency of activities and in minimising the records-management burden. The change in legislation as a result of the [European] Clinical Trials Directive and the fact that any organisation participating in a clinical trial can expect to be inspected, calls for clear documentation of the transfer of Sponsor tasks and responsibilities and a need to know exactly where records will be found (and just as importantly, will not be found) during and after the trial.

The author recommends the use of a simple tool, the STAR Matrix, to help manage the Standards, Tasks and Responsibilities of all parties involved in a clinical trial. This document both describes the STAR Matrix and provides some guidelines on its use both for new trials and as a tool for documenting currently running trials.

What is a STAR Matrix?

A two-dimensional table with rows of study-related tasks and columns detailing responsibilities and standards to be used in relation to the specific task (a row within the table). It is simple to generate on paper, in a word-processor or a spreadsheet. It requires little training and is understandable by all types of staff. There are a few simple rules to aid its completion.

An example extract from a filled matrix is shown below:

Task Responsibility Contract SOPs and Standards Training Required Records Management Archive Location
Monitoring Investigator Sites ABC ABC contract with Sponsor, XYZ under contract to ABC ABC SOP no 11 Routine Monitoring; ABC SOP 12 SDV, Sponsor SOP F221 (Handling of Suspected Fraud), Project Monitoring Plan NO (a) Originators send to Sponsor TMF monthly Sponsor
Sample Shipment Universal Exports, AMcD, CF Y UE SOP YES (sites) Originator sends to TMF Sponsor
Clinical Database Production Data Management Contractor Data Management Contractor contract with Sponsor Sponsor SOP 777 (Co-Ordinating DM and Stats); DM Contractor SOP NO Required for TMF only; others at DM contractor
Site Identification Sponsor Not Applicable Sponsor SOP 666 (Site selection) NO(b)

STAR Matrix Columns

In discussing the columns it should be noted that a STAR Matrix initially consists of an empty table (with the possible exception of rows of tasks if a template is used) and that the first pass at completing the table will result in many empty cells. Although best kept to the width of a single page, you can decide upon any number of columns, and any appropriate column contents, but, as a minimum it must contain:-

Task

A specific sub-task within a study - the level of breakdown of a study into tasks should be at a low enough level to allow proper (and most importantly, specific) allocation of duties to contractors (or the sponsor) as well as reference to specific SOPs or standards. Sometimes you might need to split a task, or rename it so that you can allocate responsibilities correctly.

Responsibility

The organisation or individual responsible - there should be only one name listed per row (otherwise management will slip as it will not be clear who is responsible) but the initials of individuals within the sponsor organisation with responsibility for oversight of the contractor may also be included. If it is seems necessary to list more than one name then it is an indication that the task needs to be divided (that is, split into more than one row and possibly be renamed - for example a CRO might be responsible for designing a CRF, whereas the Sponsor is responsible for approving the CRF design). This leads us to our first Golden Rule:

There must be one, and only one, organisation or individual per responsibility cell

Contract

Whether or not a contract exists for the task and preferably, the contract reference (although this is unlikely to be known when starting a Matrix from scratch).

SOPs and Standards

The relevant operating standards that the parties involved in the task agree to be bound by and to operate by. In some cases a contractor might agree to operate with a Sponsor's SOPs and standards, or use its own. In many organisations there are Project-specific standards that include the detail and project-relevance of standards that aren't appropriate in SOPs, for example Monitoring Plan, SDV Plan, Data Management Plan.

Training Required

Whether project-specific or additional training is required, for example training of CRO personnel asked to follow a Sponsor's Pharmacovigilance SOP.

Records Management

To describe where the records generated for each task will be held held during the conduct of a project (or task, if that is more appropriate). This might include retention by the originator, transfer to the Sponsor or transfer to the organisation responsible for maintaining the Sponsor's Trial Master File (TMF)

Archive Location

The final archive destination of the records for each trial task, which might include more than one archive location, for example the originator's archive, the Sponsor's archive or a contract archive service.

STAR Matrix Rows

The rows will depend upon the user and purpose of the STAR Matrix (see below), and might include all or some of the following:-

Using a STAR Matrix

Sponsor Allocation of Responsibilities

Prior to initiating a trial the Sponsor should define, establish and allocate all trial-related duties and functions.1 This is a requirement regardless of the involvement of any contract organisation. By listing duties and functions (tasks) in detail in a single place it becomes much easier to spot any gaps or overlaps in responsibilities or tasks. Our second golden rule which aids this (when completing a new STAR Matrix, at least) is:

There should be no empty columns for a task prior to starting that task

Ensuring Consistency

One of the reasons, in fact the stated reason 2 for having SOPs in clinical research is to achieve uniformity of the performance of a specific function. For any tasks that are allocated to a number of different organisations (for example monitoring) it can become unclear which (or whose) SOP should be followed by which organisation in which circumstances. Using the SOPs and Standards column in the STAR Matrix the Sponsor or Project Manager can see any potential for undesirable or unexpected inconsistency.

Adding Another Dimension - Colour

Colour can be used to add an additional layer of information, without having to add more columns, for example to highlight

Or in the example extracted from a STAR Matrix below, to highlight tasks or duties allocated to a specific party, in this case the Sponsor:

Task

Responsibility

Contract

SOPs and Standards

Training Required

Records Management

Archive Location

Audit Plan Development

File-Away Limited

File-Away Master Service Agreement plus Approved Audit Plan

Sponsor SOP 101 Routine Audits

NO

Originator retains during trial and copies to Project Manager

Sponsor

Audit Plan Approval

Sponsor

Not applicable

Sponsor SOP 101 Routine Audits

NO

Originator sends to Project Manager

Sponsor

Audit Conduct and Reporting

File-Away Limited

File-Away Master Service Agreement plus Approved Audit Plan

Sponsor SOP 101 Routine Audits

NO

Audit Reports sent to Project Manager and Sponsor Head of Clinical Development on completion

Audit Certificates to TMF

Sponsor

Audit Follow-up

Sponsor

Not Applicable

Sponsor SOP 101 Routine Audits

NO

Originator sends to Project Manager

Sponsor

Coordinate Regulatory Inspection (if required)

Sponsor

Not Applicable

Sponsor SOP 999

Coordinating Regulatory Inspections

NO

Documentation to named personnel according to SOP 999

Sponsor

© 2003 Janice V Birnie

Comments to the author, by email: jvb@hunterbirnie.com

References