Tag Archives: data management clinical

Introduction to Clinical Trials

Video introducing cancer clinical trials and their use in clinical practice guidelines

-FAIR USE-
“Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for “fair use” for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational or personal use tips the balance in favor of fair use.”

Source: Cancer Guidelines – Canada

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Standard Naming Conventions for InForm Trials

This document is intended to provide a common set of rules to apply to the naming of clinical trials build using InForm EDC system.

Why use naming conventions?

Naming objects consistently, logically and in a predictable way will distinguish similar records from one another at a glance, and by doing so will facilitate the storage and retrieval of records, which will enable users to browse clinical objects more effectively and efficiently. Naming records according to agreed conventions should also make object naming easier for colleagues because they will not have to ‘re-think’ the process each time.

It has been said that InForm follows the “Hungarian” notation because it is one of Microsoft’s “Best Practices” for .Net standards when defining objects (the code to support those objects use it).

Component Prefix
Form (e.g., frmDemo…) frm
Section sct
Itemset its
Radio Control rdc
Item itm
Pulldown Control pdc
Text box txt
Date and time dtm
Group Control grp
Checkbox chk
Calculated Control cal
Simples smp
Study Element elm
Codelist cl
Study Event evt
Codelist Item citm
Workflow Rule wr
Global Conditions gc
Data Entry Rules (e.g., rulDMConsDTCompare) rul
DataType Prefix
Boolean bln
Byte byt
Character chr
Date dtm
Decimal dec
Double Precision dbl
Integer int
Long Integer lng
Object obj
Short Integer sht
Single Precision sng
String str
User-defined Type udt
Object Prefix
Button btn
CheckBox chk
ComboBox cbo
Control ctr
DataSet ds
DataTable dt
Form frm
GroupBox grp
Label lbl
ListBox lst
PictureBox pic
RadioButton rdb
String str
TextBox txt

Remember keep it consistent. This means that you stick to one particular pattern through out your clinical project. This also includes the words you use for namespaces, classes, methods, interfaces, properties and variables. A prerequisite is that they should be meaningful, significant, descriptive and easily understood with respect to purpose and functionality by anyone who reads the source code.

Happy Programming!


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.

Project Management Forms and Deliverables

Project Management Forms & Deliverables Checklist

Deliverable Description Purpose
Project Checklist Checklist of tasks that a Project Leader should be doing at a particular phase in the project. Used to remind a Project Leader of all the tasks and areas to be concerned with when managing a project.
Project Proposal A form used to capture the initial ‘good idea’ or ‘we need something’ information for a project. Used to communicate initial project goals and objectives, anticipated benefits, risks, CSF’s and project organization. Used to get approval to proceed to the Planning phase where you develop a project charter
Project Contracting Form A form used to outline key results, stakeholders, milestones, and scope dimensions. Used to identify key project initiation elements. Used to make sure all project dimensions are considered.
Project Charter Serves as an agreement between the Project Leader and the Project Sponsor for what the project will deliver. Used to establish a common understanding of the project, what will be produced or delivered, when and by whom. It also details the strategies that will be used to manage the project.
Project Charter Presentation Presentation format for a PM to complete that summarizes the key features of a project Used when presenting a charter for approval or to a project sponsor or owner. Because it is a summarization, it is useful for presenting information to people who have not read a project charter.
Roles & Responsibility Matrix A matrix that lists team members and all the major deliverables or activities that are being produced for the project. An individual’s relationship to a task (Responsible, Contributes, Reviews or Approves) is indicated in the intersection of resource and task Used to explicitly document who is responsible for producing deliverables.
Communications Plan Details the structure, form, type and frequency of communication. Also details the communication paths and key communications milestones that should occur on the project Used to establish lines of communication to ensure that project information is communicated and received by its intended audience. Also ensures that key groups are not left out of the communication loop. Also provides a way of evaluating how the communication is working throughout the project.
Communication Log Log that records when, to whom and in what format communication occurred. Used to track actual communication events back to planned communications to ensure that all groups are receiving and sending communication on a timely basis.
Change Request Form Form for requesting changes to a project Used to capture details related to a change request and implications of accepting a change. Supports a formalized change process
Change Log Contains a history of issues and their resolution. Used to capture, track and manage change requests that are received by the project. Supports a formalized procedure for requesting changes
Design Review Form Sign-off form that design specifications and requirements are approved. Used to confirm designs in walkthroughs.
Issue Form Form for recording an issue. Used to capture issues in detail. Can be used by anyone involved in the project.
Issue Log Contains a history of issues and their resolution. Used to capture, track and manage project issues and their resolution.
Meeting Summary Form to document decisions made at meetings. Used to summarize decisions made and communicate action items and issues found during meetings
Status Report Status form. Used to communicate status.
Status Summary Checklist of questions related to project status. Used to remind Project Leaders to think about status on a larger scale.
Reviewer Comment form Form to capture specific comments for walkthroughs. Usually distributed with a document that is being reviewed and used to capture comments from reviewers.
Risk Assessment Questionnaire A questionnaire that all project leaders should fill out that will indicate the level of risk for their project. It will produce a risk radar graph when completed. Used to focus a project leader on potential risks for the project. A risk management plan can be developed that addresses the higher risks on the project
Risk Management Form A template for documenting project risk, risk management strategies and contingency plans. Used to produce a comprehensive risk management plan.
Project Close-out Form to record details of the project once it is completed Used to capture lessons learned and summarize how the project went. Can be used in a facilitated session or be completed by the Project Leader at the end of a project.

Source:Project Management Institute


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.

The Next Best Thing – Timaeus Trial Builder?

First of all, let me clarify by saying that I am not an expert when it comes to Timaeus. I recently came across this EDC tool while working on a project. We were testing out different EDC applications as part of their new infrastructure solution.

At first, I was hesitant to learn about it. All I knew was that you need it to know ‘Python’. The main programming language for their edit checks/validations and back-end structure but after my first encounter with the tool, I changed my mind. This is one of the easiest tool to use and deploy your clinical study you can find in the market, nowadays.

With that being said, What is Timaeus? This another EDC tool, trial builder application provided by Cmed Technology www.cmedresearch.com which helps build eCRF (data entry screens), edit checks/validations, external loading data and other config files.

In order to grasp this new tool, you will need to familiarize yourself with other technologies such as HTML, XML, Emacs, SVN, Python and the like and understand the TMPL element concept.

TMPL stands for “Timaeus Markup Language”. It has a bit of pieces of codes similar to what you see in HTML or XML files.

Even though the system is lacking of front-end features we are so used to in comparison with similar EDC solutions, nevertheless, this tool gets my thumps up for ease of use, cost-effectiveness, change control capabilities and one of the most robust security systems to capture electronic records as per CFR11 regulations.

Central Designer aCRF Generation

aCRF casebook ;- PDF file

1. Project Explorer – click on the 2nd level study name

2. File ->; Annotated Study Book Options

3. Uncheck Time and Events table

4. Uncheck Study Object Description Tables
5. Change date variable format to match eCRF ;map, setting is not noted on aCRF output

6. File ->; View Annotated Study Book

7. Pop up screen, click Print in lower right

8. Select Printer – Adobe PDF (single click)
9. Click Preferences

10. Click on Layout tab
11. Change to Landscape

12. Click on Advance tab in lower right

13. Change Scaling as needed, check PDF output as needed

14. Select Print, wait for file name box, aCRF is done.

Time and Events Table – CSV file

1. File ->; Annotated Study Book Options

2. Check Time and Events Table

3. File ->; View Annotated Study Book

4. Click on Save Time & Events as button lower left

5. Give it a file name

Note: ;Steps 1-5 have to be repeated every time as aCRF defaults back to base settings after you close out the study.


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.

InForm Trial – Complete Trial Removal

Remove a Trial from InForm

1-Open the command promptCommand Prompt

2-if the InForm Service has not started yet, you can start it by entering the following command:

net start pfservice  

NOTE: If you are using InForm Architect, the service may has already be started.

3-Once the server or service is started (completed successfully), you will then remove the trial by entering:

pfadmin remove trial e.g. pfadmin remove trial proto999

NOTE:  InForm can not remove a running trial. 

4-    Enter the following command prior to the remove command above:

pfadmin stop server proto999 /trials
 

Removal of a trial from the system

It is necessary to remove trials off your system once you have completed the e-crfs to ensure that Architect is working efficiently as you develop more trial e-crfs. 

1- Open the  Data Sources (ODBC)
2- Click on the tab System DSN
3- Highlight the trial that you want to remove.
4- Click the Remove button.

A message will pop up that asks you if you are sure you want to remove the trial’s data source, click Yes button. Click OK button to close ODBC.

Remove a Trial from the Oracle Database

If you are doing trial development work in Architect, you may need to stop the InForm Service before doing these steps. Enter the following command:

net stop pfservice [enter]

sqlplus useruid/pwduid [enter]

SQL*Plus is running now

From here enter the following two commands:

 drop user trialuid cascade;

commit;

 To exit SQL*Plus enter:  exit

The trial has been completely removed from the system. Doing this can help keep the system ‘clean’ as well as gets the system ready to fully reinstall this trial again if you needed to fully remove it.

NOTE: If you wish, you may verify that the trial is really gone in Oracle by starting TOAD or PLSQL Developer and check the USER object/table.


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.

FDA Compliance: Part 11 Checklist

PART 11 Checklist

Rule Sec. Requirement Satisfied?
11.10(a) Validation of Systems The system is validated (Documentation, Testing and Maintenance) Yes/NO/NA
11.10(k-1) Adequate controls over documentation Controls are present for the distribution, access and use of systems documentation for operation and maintenance Yes/NO/NA
11.10(d) Limiting system access System access is limited to only authorized individuals. Yes/NO/NA
11.10(i) Persons who develop,…have the education, training, and experience There is evidence of qualification (education, training or experience) for persons
who developed the system.
Yes/NO/NA
11.10(i) Persons who maintain,…have the education,training, and experience There is evidence of qualifications (education, training or experience) for persons
who maintain the system
Yes/NO/NA
11.10(i) Persons who…use…have the education, training,
and experience…
There is evidence of qualifications (education, training or experience) for persons
who use the system.
Yes/NO/NA
11.10(i) Written policies…for actions initiated
under…electronic
signatures
If electronic signatures are used, a policy is actively implemented, so that individuals
understand the significance of, and are held accountable for, their electronic
signatures.
Yes/NO/NA
11.10(a) Ability to discern invalid or altered records There is a method to detect changes made to records (including direct record changes that
bypass system controls).
Yes/NO/NA
11.10(c) Protection of records… There is a method to protect records from accidental
or deliberate damage (including direct record changes that bypass system controls
Yes/NO/NA
11.10(b) Generate accurate and complete copies…in both human readable… The system has the ability to produce complete copies of records in printed human
readable format
Yes/NO/NA
11.10(b) Generate…in…electronic form… The system has the ability to produce complete copies of records in a common
electronic format (e.g., ASCII, TXT, DOC, XLS, etc.).
Yes/NO/NA
11.10(f) Enforce permitted sequencing of steps and events… The system controls the required sequencing of steps and events, as appropriate. Yes/NO/NA
11.10(h) Use of device checks… The system checks that data entries or operating instructions originate only from
authorized locations (e.g., work‐stations),
as appropriate.
Yes/NO/NA

Source:FDA CFR Part11

Why use JReview for your Clinical Trials?

Issues with existing database query tools:
– Limited resources for current database query tools (Crystal Report, SQLServer, etc.)
– Custom reports in SQL Servers required validation
– Reports are not globally accessible.

Why chose Integrated Review?

  • Offers flexibility to the users when viewing the data
  • Users can create their own reports without validation
  • Provides a way for Clinical Data Managers to have real-time access to query and browse clinical patient data in our databases
  • IReview/JReview can then reference the “nonnative” database object using the Foreign Panel and/or ImportSQL capabilities. The result is that the user can remain working in one environment and reference the data that is located in other environments.
  • Easy to setup – no programming, no data extraction or data manipulation required.
  • Generate PDFs directly – for all patients selected

“I-Review would be used solely for cleaning data – providing highest data integrity prior to stats analysis.”

Why use a Patient Profile

  • When you want to review data from multiple Tables for a single subject Describe the factors or characteristics that are deemed critical to the success of a project, such that, in their absence the project will fail.
  • Very powerful when used with a Cross Tab report to provide the detail needed to investigate a finding.
  • Special case review such as SAEs or event adjudication.
  • Provides data to support the narrative writing team.

Advantages

  • Easy to build
  • Excel exportable file
  • Multiple subjects in a single report

Limitations

  • Poor readability
  • Output limited to 13 columns of data per row
  • Can’t edit column headers
  • Page header data is limited to 3 items
  • There is no option to use free text in the header or footer

Formatted Style
Advantages

  • High readability PDF style output which also prevents the manipulation of data
  • Free text entry for page header and footer can be used to add key notations to the report
  • Column header text can be edited to enable use of intuitive labels instead of database codes
  • Scheduling feature allows for running batches of patients and exporting outputs as a group
  • Bookmarks in output allow for quick navigation to data
  • Limitations
  • Creation of profile can be slow in the tool use scheduler
  • Can be very time consuming to develop (use a global template)

Object Storage

  • Private (local accessible by the user only) vs Public (accessible by all users)
  • Usergroup (i.e. CDS, CDM, Clinical, biostat, etc)

Object Level

  • Study (at least one view (object) at the study level)
  • Project (a mixture of project and global level and available across the entire project)
  • StudyGroup
  • Global

Keys to Success

  • Think about your audience – Clinical or Data Managers
  • The goal is to provide a report which is easy to read
  • Develop a “template” using standard modules and data items
  • Establish standard formats all parts of the report
  • Font size
  • Text alignment
  • Page margins
  • Use the same formatting for protocol specific elements


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.

Did You Know?

Did You Know? »

You can hide temporary SAS datasets by adding a prefix of “_to” and your temporary datasets will not show up in the Work folder in the Explorer window.

e.g. work._toEDC

Remember, temporary datasets are removed at the end of your SAS session.

data work._toPK;
set pk;
rename pkcolt=tm01;
where pkhrs=0.1 ;
run;


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.