All posts by anayansigamboa

Cartoon of the Day – RMS

Revenue Management Systems by various Cartoonist

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.”

Did You Know?

Did You Know? »

SAS comments are represented in two ways:

**************************************************;
*Name runlst.sas                                 *;
* Version 1.0                                    *;
* Date  2011                                     *;
* Purpose:  CDM Listings                         *;
**************************************************;

OR this way /* This is my SAS Program */

You can comment out text in the Enhanced Editor in SAS by:

  • Position the cursor in, the line of code you wish to comment out, then press Ctrl + /.
  • If the text is already commented out (with /* and */), you can remove the commenting by highlighting, or positioning the cursor in the text and pressing Ctrl + Shift + /.

Did You Know?

Did You Know? »

The most common errors a SAS programmer makes are:

  • Omiting the semicolon (;).

e.g. proc print data=demog

Error Log message=syntax error, expecting one of the following…

  • Misspelling a word

e.g. data demog; set demog;… proc print data=demo;

Error Log message=File work.demo.data does not exist

  • Omitting the RUN statement (run;)

e.g. proc print data=demo;

Error Log message=no output appears in the output window until the next proc step is submitted.

And my favorite error..

  • Omitting required quotation marks (”)

e.g. title ‘EDC Status Report ;

Error Log message=the TITLE statement is ambiguous due to invalid options or unquoted text.

Remember, practice makes perfect!

Making Public Folders Hidden to Users in Cognos

As a BI Administrator, you might want to hide certain public folders to some users. You can do this by:

  1. In Public Folders > click the Create a Folder icon and create a folder called “eClinical Documents”.
  2. In Public Folders > click the Create a Folder icon and create a folder called “eClinical”.
  3. Within the “eClinical Documents” folder created in step 1, create a Page called “eClinical Portal”:
  • One Column 
  • Add Cognos Content – Cognos Navigator
  • Add Page as a “Portal tab”. 

4.  In “Directory”> Cognos namespace, edit the “Default User Profile”:

    • In the Default User profile, select Portal Tabs > delete Public Folders
    • In Portal Tabs > select Add Portal tab Page and add the “Your Company Portal” page created in step 3.
    • Modify the sequence so that “Your Company Portal” appears first in the list. 

5.  Copy this profile to existing Users (if necessary).

6.  Within the “eClinical” folder created in step 2, select Create Divisional/BU/Departmental folders as necessary.

7.  Add the necessary security (Execute & Traverse) to the folders.

Note: All Reports written against Packages need to be saved into the relevant folders created previously.

8.  Click on the new Portal Tab “eClinical Portal” and select “Edit” to change the Cognos Navigator Content:

    • Under the “Folder” option, select the “eClinical” folder created in step 2.
    • Choose to “Open Links” in the current window.
    • In the “Features to expose in the Navigator views” option, ensure that the only boxes selected are the “Additional Information – Normal Mode” and “Maximised Mode”.
    • Set the number of Columns as appropriate. 

Note: Individual users are still allowed, once logged in, to remove from their view the Portal Tab(s) that were created – and they can easily put them back using the Tab Menu.

it jobs, job employment, it recruitment, agencies

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.

Oracle Clinical – How to Use Study Design

Study Design in OC is the process of setting up the protocol for the study. This includes:

  •  creating a record for the study
  • creating patient positions or placeholders
  • creating events or study visits
  • assigning sites or locations where data is collected
  • assigning patient positions to the site

Remember that the required study planning objects, sites and investigators must be created prior to the Design Process being completed.

It is a good idea to review all protocol and study related documentation prior to creating the study to make sure you have all of the necessary information but you can always change the Design elements at any time except for the study name.

Once the Study Design is completed, you can move to the next module: The Study Definition (creating CRFs) and develop Procedures (Edit Checks, derivations).

Tips:

  •  Records for the new studies are created in the Easy Design module (Design, Studies, Easy Design)
  • Verify that the required Planning Objects exist for the study
  • In the Easy Design form create the study. Enter the study name or number, version and study description/title. Some parameters are optional. Once you click save, the system will prompt you to choose whether the study requires Pass 2 Data Entry.
  • Most Study Design parameters may be changed except fr the Study Name

Study Design Key Terms:

  • Program: Code (name) for the compound being investigated
  • Protocol: Document describing the plan of action for a study
  • Project: Code (name) for the indication under investigation
  • Study: The name for the Clinical Study
  • Organizational Unit: Code (name) for the unit responsible for the study
  • Event: Clinical Planned Event or Visits
  • Region: Code (name) of the location where the study is managed
  • Patient Positions: Identifier for a participant in a study
  • Site: A location where all or part of the study is conducted
  • Investigator: Primary researcher/clinician for the study at a site

Study Design – Events

• Study timeline is used to identify when data is collected or for tracking purposes (missing or overdue DCMs)

• Consists of one or more intervals and one or more events (visits)

• Timeline consists of intervals that are subdivided into events. By default each study is pre-populated with two defaults intervals that can be used in creating events.

• To create intervals, select the study in the Easy Design module and click on Intervals. Intervals are defined by a Phase Name, Short Name, Phase Type, Blind type (single, double, etc) and a minimum and maximum duration. The duration is used to calculate when the interval is expected to take place within the study.

• To create events, select the study in the Easy Design module and click on Events. Create all the events (visits) in which data will be collected during the course of the study. Events are defined by Event Name, Interval, Visit Number (the order o f the event is expected to occur) and minimum and maximum Offsets from the Interval Start.

• Time calculations (event offsets and interval durations) are useful only for descriptive purposes and for determining if expected CRFs are Missing or Overdue.

If this functionality is not required then this information is not useful in the execution of the study.

Study Design – Patient Positions

• Patient Positions are the placeholders for the actual partaker in the study. Each patient for whom data will be collected must have a unique patient position within that study.

• Can be crated in blocks or one-by-one.

• Patients can be of several types: Screening, Normal or Replacement.

For general patients, use NORMAL.

Replacements are used in Randomization.

• To create patient positions, select the study in the Easy Design module; click on Create PP. Create the required patient position for the study by entering starting and ending numbers.

• Duplicates numbers are not allowed within a study.

Study Design – Sites and Investigators

• Sites are the locations where the data is collected and investigators represent the medical researcher at the site responsible for the patients. It can be used in multiple studies.

• Each study requires a minimum of one site assigned to it with an investigator assigned to that site.

• Create Sites in the Sites module. A site is defined by a Code, Name, Phone Number, Address, City, State, Country, and Postal Code. Site code must be unique.

Design ->Investigators and Sites -> Sites

Create Investigators in the Investigators module. An Investigator is defined by a Investigator Code, First Name, Last Name, and Phone Number. Other information is optional. Investigator code must be unique.

Design -> Investigators and Sites ->Investigators

• Assign an Investigator to each site. There can only be one active Investigator assigned to a site at any time. If a second Investigator is assigned to the same Site, the system automatically enters a Termination Date for the current Investigator.

• Assign Patient Positions to the Study Sites. Patients may be optionally enrolled in the study. Enrolling patients can be performed in the Enrollment module.

Tip: The system only requires the enrollment date to consider a patient “Enrolled”, however, the lab range system will not work without the entry of the patient’s birth date and sex.


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.

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

Audit Record Status in Clintrial

Did you ever wonder what the various status designations used for records in the audit table mean?

Audit table record status is contingent on:

  • The record’s status at the time it was modified or deleted.
  • The database table where the record was stored (update or data).

Audit Table
Status prior to change: Table location prior to change: Audit table code if modified: Audit table code if deleted:
Entered Update -60 -61
Verification Error Update -50 -51
Verified Update -40 -41
Validation Error Update -30 -31
Validated Update -20 -21
Validated Data -10 -11

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.