Tag Archives: CRA

How to Manage Sites and Users in InForm Trial?

So you created your first InForm Trial and now what? Before you can actually enter data into your trial, you need to set up a user management system which assigns permissions to different users in your system depending on their job “role”.

In InForm, this is accomplished by using a tool called ‘User Management Tool’ or simple UMT. This tool allows sponsor to manage sites and users once the trial have gone live. There may be many different user groups with different levels and ranges of permissions.

Creating an InForm Trial – UMT:

  1. Create your InForm trial in the UMT. I won’t go into details on how to actually do this and depend upon the contract agreement with the vendor (i.e. Oracle/PhaseForward); they will perform this task for you.
  2. Select Trial Version = latest InForm version (i.e. 5.0)
  3. Select Countries where this trial will take place
  4. Select Status. Each InForm trial has 4 main statuses.
    1. Fast Start = Pre-Go Live
    2. Fast Forward = Trial is now live
    3. Fast Lock = Trial is lock
    4. Decommission = Trial is completed/archived

Managing users and groups can be a tedious task but tools such as UMT makes them easier to manage.

Roles: Roles (e.g. CRA, PI, System Administrator, etc) are used to assign specific permissions to individual users or groups, typically to perform specific functions in the InForm system.

The system allows you to either manually enter a role or import using a template called ‘MUL’ or Masters Users List. If you decided to upload your rights and roles via MUL, the system will generate a log file. It is imperative that you check this file and check any errors before proceeding.

Once the roles have been added to the UMT, you need to approved them before you build your clinical trial. The system also comes with defaulted and approved rights and roles.

Another option available is to create what is called as ‘signature groups’. If you are familiar with Medidata Rave system, this is equivalent to checking the ‘Signature required’ box and setting the investigator signature in Architect project main page.

Common use of Signatures in clinical trials are at the form level (i.e. 1 signature per form or at the subject level or studybook = 1 signature per subject).

Item Groups: Items groups is used to overrides or restrict a particular user access to a form or field. This is equivalent to ‘Restrictions – View/Entry’ in Medidata Rave.

One good example of display override usage is the coding fields restrictions. If only Clinical Coders are allowed to view / entry data on those items, you will limit access to all roles but the coders role.

Here’s a snippet of the code in .XML:

<!–?xml version=”1.0″?>–>
<MEDMLDATA xmlns=”PhaseForward-MedML-Inform4″>
/*some other code goes here*/
<ITEMGROUP
GROUPNAME=”Hidden Coding Items”
GROUPDESCRIPTION=”Hidden Coding Items”>
<!– Insert ItemRef Names –>
<ITEMREF REFNAME=”PT_NAME”/>
<ITEMREF REFNAME=”HLGT_NAME”/>
<ITEMREF REFNAME=”HLT_NAME”/>
<ITEMREF REFNAME=”LLT_NAME”/>
<ITEMREF REFNAME=”SOC_NAME”/>
</ITEMGROUP>
</MEDMLDATA>

Two other important groups that you need to be aware of is the Query and the Report Groups. The former, as the name entails, allows a user to open, answer, reissue and close queries during the course of a clinical trial. The latter, allows a particular user to run reports.

For example, an Ad Hoc User can access Ad Hoc reports via Cognos. The roles associated to this group could be your project manager, Clinical Research Associate (CRA) or your Lead Data Manager (LDM/CDM).

Once you have completed your basic setup, you will need to prepare or cook those xmls files onto your clinical trial. The rights/roles we discussed needs to be in an approved status. You also want to make sure you ‘lock for QC’ or lock the trial to prevent anyone from making changes to already added sites/users.

Sites and Users marked for upload to InForm will automatically be cooked into your trial.

Last step we need to take is to generate the XML files by selecting the link ‘Generate InFormXML.’ Now, your UAT trial is created, your URL is set up and you are ready to perform User Acceptance Testing.

Remember to validate your XML files, especially if your clinical trial is running across several countries. I have found issues with foreign languages symbols or special characters entered in the UMT system. Avoid at all cost any special characters.

Source: User Management Tool Reference Guide from PhaseFoward

Your comments and questions are valued and encouraged.
Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica, Open Source and Oracle Clinical.

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Data Management Plan in Clinical Trials

 

The preparation of the data management plan (DMP) is a simple, straightforward approach designed to promote and ensure comprehensive project planning.

The data management plan typically contains the following items. They are:

  1. Introduction/Purpose of the document
  2. Scope of application/Definitions
  3. Abbreviations
  4. Who/what/where/when
  5. Project Schedule/Major Project Milestones
  6. Updates of the DMP
  7. Appendix

The objective of this guidelines is to define the general content of the Data Management Plan (DMP) and the procedures for developing and maintaining this document.

The abbreviation section could include all acronyms used within a particular study for further clarification.

e.g. CRF = Case Report Form
TA = Therapeutic Area

The Who/What/Where/When section should describe the objective of the study specific data management plans for ABC study. This section provides detail information about the indications, the number of subjects planned for the study, countries participating in the clinical trial, monitoring guidelines (SDV) or partial SDV, if any CROs or 3rd party are involved in the study (e.g. IVRS, central labs), which database will be used to collect study information (e.g. Clintrial, Oracle Clinical, Medidata Rave or Inform EDC).

The Appendix provides a place to put supporting information, allowing the body of the DMP to be kept concise and at more summary levels. For example, you could document Database Access of team members, Self-evident correction plan, Data Entry plan if using Double-data entry systems or Paper-Based clinical trials systems.

Remember, this is a living document and must be updated throughout the course of the clinical trial.

If problems arise during the life of a project, our first hunch would be that the project was not properly planned.

Reference: Role of Project Management in Clinical Trials
Your comments and questions are valued and encouraged.
Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica, Open Source and Oracle Clinical.

To hire me for services, you may contact me via Contact Me OR Join me on LinkedIn

Disclaimer: The legal entity on this blog is registered as Doing Business As (DBA) – Trade Name – Fictitious Name – Assumed Name as “GAMBOA”.

Adverse Event Monitoring for CRAs

During monitoring visits one of the most important and impacting activities that a CRA performs is the source document verification of Adverse Events. The CRA is the eyes for the research sponsor when it comes to proper collection and documentation of subject safety information. Incorrect and inadequate monitoring of adverse events can lead to inaccurate labeling for clinical trials and impact market application inspectional reviews, as well as post marketing labeling. The safety regulatory and ICH definitions will be reviewed and applied to the monitoring process. This includes Causality, Expectedness/Unanticipated, and other important concepts. Case scenarios will be used to apply the information for better learning.

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One Bad Day in a CRA’s Life

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Role of Project Management and the Project Manager in Clinical Data Management

 

The Project Manager is responsible for the development, oversight of implementation, and communication of clinical research studies.

So what is a Project?

A project is a work effort with a definite beginning and end, an identifiable end result (deliverable), and usually has limits on resources, costs and/or schedule.

What is Project Management?

The application of knowledge, skills, tools, and techniques to project tasks in order to meet project requirements.

In order to be a successful project manager, you need to understand the “Tripple Constraint” and how they affect your project. Let’s look up the WBS-edit checks:

Note: I will refer a project = clinical study

Scope: What is in the contract? How many edit checks, SAS checks and manual checks are required in this study? What is the effort per edit check, SAS check and manual check?

The goal is to convert the idea of data management to that of statistical analysis – an analyzable database.

Time: What are the deliverables and timelines? What resources are needed?

Cost: What are the budget restrictions? Are there any risks associated with any changes?

Project Planning: During the planning of a clinical study, we identify the project scope, develop the project management plan and we identify and schedule the clinical study activities.

Some questions might arise during the project planning phase: how many sites/subjects and pages will be collected?Who will attend team meetings? what study fields will be code (i.e. Adverse Event term)?

Other important activities that the project manager and clinical team members will need to be involved:

Work Break Down (WBS) – it is the list of activities that will be performed during the course of a clinical study.

Resourcing – it is important to assign the right person to a particular task based on skills, education and experience.

ICH Guidelines ‘…all personnel involved in clinical trials must be qualified and properly trained to perform their respective tasks…’

Estimating Cost – look at historical data as well as good estimates from effort per unit and units using your WBS as references.

Scheduling and Budgeting – you will be able to build schedules and budgets that transform project constraints into project success after you successfully construct your Work Breakdown Structures (WBS) and network diagrams and estimate task durations.

Projects managers used techniques for employed to establish project. Project Manager can decide which activity can be delayed without affecting the duration of the projects. They help improving quality and reduce the risks and costs related with the projects.

A recent survey by the Project Management Institute provided 10 challenges affecting project managers. This research intended to identify key factors affecting project team performance:

  1. Changes to Project Scope (Scope Creep)
  2. Resources are Inadequate (Excluding Funding)
  3. Insufficient Time to Complete the Project
  4. Critical Requirements are Unspecified or Missing
  5. Inadequate Project Testing
  6. Critical Project Tasks are Delivered Late
  7. Key Team Members Lack Adequate Authority
  8. The Project Sponsor is Unavailable to Approve Strategic Decisions
  9. Insufficient Project Funding
  10. Key Team Members Lack Critical Skills

Another question to ask is what tools are available to help you get the job done?

  1. Resource allocation (and the software’s ability to easily display staff who were overallocated)
  2. Web-based/SaaS option
  3. Cost/Price of the system (big one!)
  4. Contractual terms we could enter into (i.e. 6 months, 12 months, month to month)
  5. Ability to demo the software and for how long
  6. What sort of customizations could be made to the software after purchase
  7. Types of customers the software has served
  8. Report types
  9. Ability to sync with accounting software and which ones, if so
  10. Timeline generation capabilities and import function with MS Project
  11. Ability to create template projects
  12. Ability to alert on early warning signs (i.e. budget overruns over 10%)

It is suggestted that you review each suggestion on project management tool very, very carefully to determine how it fits your processes.

Your organization’s processes are unique to your organization; no other organization anywhere has quite the same processes. So what may work for one organization may not necessarily work for you. Your organization developed its processes to suit your particular corporate culture, the particular collective character attributes of the employees (their experience, etc.), the type of projects that you execute and the particular types customers/clients that you have (especially the regular ones).

You now have to make sure that the tools you choose work for you and your particular processes. Do not change your processes again to suit whatever workflow (process) is dictated by the fancy tool that the fancy salesman sold to you; you are likely to find that the tool-dictated workflows do not work that well in your organization, with the result that the employees will give up following processes and/or give up using the tool, throwing everything into chaos again.

Be careful if you are looking at tools that offer to do a number of different functions or can be made to do any function you want it to do. They seldom do the job that you bought it for particularly well. For example, I have worked with a tool that was advertised as a combination issue tracking and defect/bug tracking tool. It was used as a defect tracking tool but it was very poor; it was tremendously difficult to make it prepare useful reports. A hand-written tool set up in a spreadsheet (e.g. Microsoft Excel) or database (e.g. Microsoft Access) would have worked better.

That said, there are tools out there that are specific to one particular function but do offer flexible workflows – they may be modified to match whatever processes your organization already follows.

If your organization has just started to organize the PM processes and PMO that would mean processes & other related areas are not explicitly defined. So there may be a huge risk trying to adopt an integrated and centralized project management system. It is more likely to offer you a very comprehensive, complex but expensive solution wherein your problem is still not defined completely. In such a case you are just not ready with the environment and process maturity that an integrated tool requires prior to implementation.

A more efficient approach should be iterative, incremental and adaptive in nature. That means you shall use simple, not so expensive tools with limited scope to begin with; they can be tools with basic functionalities of WBS, scheduling, traceability and custom datasheets. These tools should have capability to exchange data both ways with more commonly uses tools like MS Excel, MS Project, and Word etc. The processes are likely to mature over time and we will then know the real effectiveness of these basic tools in the context of company requirements. That may be the time to analyze and switch to more integrated solutions.

One important key to remember. The role of project management in clinical trials is evolving. There is a debate about who should be the ‘project manager’ for a particular clinical study. CRA or Clinical Data Manager or an independent project manager? Let’s review their roles within data management.

Clinical Research Associate (CRA): main function is to monitor clinical trials. He or she may work directly with the sponsor company of a clinical trial, as an independent freelancer or for a Contract Research Organization (CRO). A clinical research associate ensures compliance with the clinical trial protocol, checks clinical site activities, makes on-site visits, reviews Case Report Forms (CRFs) and communicates with clinical research investigators. A clinical research associate is usually required to possess an academic degree in Life Sciences and needs to have a good knowledge of Good clinical practice and local regulations. In the United States, the rules are codified in Title 21 of the Code of Federal Regulations. In the European Union these guidelines are part of EudraLex. In India he / she requires knowledge about schedule Y amendments in drug and cosmetic act 1945.

Clinical Data Manager (CDM): plays a key role in the setup and conduct of a clinical trial. The data collected during a clinical trial will form the basis of subsequent safety and efficacy analysis which in turn drive decision-making on product development in the pharmaceutical industry. The Clinical Data Manager will be involved in early discussions about data collection options and will then oversee development of data collection tools based on the clinical trial protocol. Once subject enrollment begins the Clinical Data Manager will ensure that data is collected, validated, complete and consistent. The Clinical Data Manager will liaise with other data providers (eg a central laboratory processing blood samples collected) and ensure that such data is transmitted securely and is consistent with other data collected in the clinical trial. At the completion of the clinical trial the Clinical Data Manager will ensure that all data expected to be captured has been accounted for and that all data management activities are complete. At this stage the data will be declared final (terminology varies but common descriptions are Database Lock and Database Freeze) and the Clinical Data Manager will transfer data for statistical analysis.

Clinical Data Management (CDMS) Tools: (we will review each of them on a separate discussion)

  • Standard Operating Procedures (SOPs)
  • The Data Management Plan (DMP)
  • Case Report Form Design (CRF)
  • Database Design and Build (DDB)
  • Validation Rules also known as edit checks
  • User Acceptance Testing (UAT)
  • Data Entry (DE)
  • Data Validation (DV)
  • Data Queries (DQ)
  • Central Laboratory Data (CLD)
  • Other External Data
  • Serious Adverse Event Reconciliation (SAE)
  • Patient Recorded Data (PRO)
  • Database finalization and Extraction
  • Metrics and Tracking – see BioClinica article on Metrics
  • Quality Control (QC)- see discussion on A QC Plan for A Quality Clinical Database

In conclusion, a key component of a successful clinical study is delivering the project rapidly and cost effectively. Project managers must balance resources, budget and schedule constraints, and ever-increasing sponsor expectations.

Source:

To hire me for services, you may contact me via Contact Me OR Join me on LinkedIn
Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica Open Source and Oracle Clinical.