Castor EDC – Data Management Made Easy!

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I recently was approached by a group of scientists that have developed a unique EDC system for researchers. Usually, you have a group of developers or gurus / geeks around some science major staff trying to understand how the EDC system they purchased works. But to hear that the system was actually developed by the scientists itself was news to me. So the email piqued my curiosity.  And as the email stated ‘our goal is make professional data management systems available for every researcher,’ I proceeded to spend time researching more.

As per my previous post, I like to ask the question about ‘names’ so here I asked the founder of Castor the same question…What is in the name besides letters? 

Castor is the Latin name for the beaver family, and the logo is designed as a safe haven (the wall around the dot) for data (the dot in the center), but still accessible, just like a beaver’s ‘lodge': hard to get into, but safe and comfortable inside.-Derk, founder

Why Castor?

Affordable multicenter EDC, GCP compliance, that is self-managed and you can do everything yourself. The system works on any platform and everybody can use it.

How to get started?

There are NO contracts or third-party involvement. You go to CastorEDC portal and click on –> Register

Anayansi Gamboa - Castor EDC

Create a new Study – once you have registered, you start building your study with ‘form builder’ tool. In order to build a form, you need to create phases (called usually visits like screening, visit 1, visit 2 and so on) and forms (that are referred by Castor EDC as ‘steps’ such as ‘Inclusion / Exclusion Criterias, Demographics, Vital Signs’, etc).

Now that you have defined your visits and forms, you need to add your fields. To the left of the form builder, you will find pre-defined set of fields from yes/no radio buttons to text fields to date fields and checkboxes. There are a lot of field types with several properties for each fields.

Another good feature is called ‘dependencies’.  For example, if you have a RACE field that collects multiple races codes including the OTHER, specify option; you can have a dependency text field appears ONLY when the OTHER option is checked.

Castor EDC Demo Castor EDC - Demo

Is Castor EDC CDISC-Compliant?

Currently, the system is being upgraded to comply with CDISC standards and this feature should be available by end of 2015.

Is castor EDC Affordable?

To calculate your own price or to have an idea of how much it will cost you to run your trial or research project, go to Pricing and Features.

Why people are choosing Castor EDC?

Reason 1 – It is fast –  your trial is up and running in days.
Reason 2 – Affordable – packages to fit any budget. No more Access or Excel to collect data.
Reason 3  – Easy to Use – Everyone can enter data with Castor EDC

Using Castor EDC is very easy, just follow these 10 steps:
1. Create your account.
2. Create your Study.
3. Build your Study structure.
4. Build forms for study data, reports for repeated data (i.e. SAE forms) and surveys for patient questionnaires (ePRO’s).
5. Test your forms via record management.
6. Check your settings , set randomization, record ID generation, and multicenter options.
7. Invite colleagues and participating researchers.
8. Set rights for every individual user.
9. Set your Study to live to start collecting real data.
10. Collect clean and valid data for your study!

Need more information?

See castoredc.com if you need affordable Electronic Data Collection for your study.

If you are looking for a study builder or clinical programmer to support your clinical trials and data management department, please use the contact form.

 

 

The Only Three (3) [Programming] Languages You Should Learn Right Now (eClinical Speaking)

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On a previous article that I wrote in 2012, I mentioned 4 programming languages that you should be learning when it comes to the development of clinical trials. Why is this important, you may ask? Clinical Trials is a method to determine if a new drug or treatment will work on disease or will it be beneficial to patients. Anayansi Gamboa - Clinical Data Management Process If you have never written a line of code in your life, you are in the right place. If you have some programming experience, but interesting in learning clinical programming, this information can be helpful.

But shouldn’t I be Learning ________?

Here are the latest eClinical programming languages you should learn:

1. SAS®: Data analysis and result reporting are two major tasks to SAS® programers. Currently, SAS is offering certifications as a Clinical Trials Programmer. Some of the skills you should learned are:

  • clinical trials process
  • accessing, managing, and transforming clinical trials data
  • statistical procedures and macro programming
  • reporting clinical trials results
  • validating clinical trial data reporting

2. ODM/XML: Operational Data Modeling or ODM uses XML to build the standard data exchange models that are being developed to support the data acquisition, exchange and archiving of operational data.

3. CDISC Language: Yes. This is not just any code. This is the standard language on clinical trials and you should be learning it right now. The future is here now. The EDC code as we know it will eventually go away as more and more vendors try to adapt their systems and technologies to meet rules and regulations. Some of the skills you should learn:

  • Annotation of variables and variable values – SDTM aCRF
  • Define XML – CDISC SDTM datasets
  • ADaM datasets – CDISC ADaM datasets

CDISC has established data standards to speed-up data review and FDA is now suggesting that soon this will become the norm. Pharmaceuticals, bio-technologies companies and many sponsors within clinical research are now better equipped to improve CDISC implementation.

Everyone should learn to code

Therefore, SAS® and XML are now cooperating. XML Engine in SAS® v9.0 is built up so one can import a wide variety of XML documentation. SAS® does what is does best – statistics, and XML does what it does best – creating reportquality tables by taking advantage of the full feature set of the publishing software. This conversation can produce report-quality tables in an automated hands-off/light out process.

Standards are more than just CDISC

If you are looking for your next career in Clinical Data Management, then SAS and CDISC SDTM should land you into the right path of career development and job security.

Conclusion: Learn the basics and advanced SAS clinical programming concepts such as reading and manipulating clinical data. Using the clinical features and basic SAS programming concepts of clinical trials, you will be able to import ADAM, CDISC or other standards for domain structure and contents into the metadata, build clinical domain target table metadata from those standards, create jobs to load clinical domains, validate the structure and content of the clinical domains based on the standards, and to generate CDISC standard define.xml files that describes the domain tables for clinical submissions.

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.

Source:

SAS Institute
CDISC

Project Plan: CDISC Implementation

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CDISC standards have been in development for many years. There are now methodologies and technologies that would make the transformation of non-standard data into CDISC-compliance with ease. Clinical trials have evolved and become more complex and this requires a new set of skills outside of clinical research – Project Management.

As with many projects, CDISC is a huge undertake. It requires resources, technology and knowledge-transfer. The industry (FDA for example) has been working on standardization for years but on September 2013, it became official, in which the FDA released a ‘Position Statement‘.

So what is CDISC? We can say that it is way of naming convention for XPT files, or field names naming conventions or rules for handling unusual data. Currently, there are two main components of CDISC: SDTM (Study Data Tabulation Model) and aDAM (Analysis Data Model).

As a project manager and with the right tool, you can look to a single source project information to manage the project through its life-cycle – from planning, through execution, to completion.

1) Define Scope: This is where you’re tested on everything that has to do with getting a project up and running: what’s in the charter, developing the preliminary scope, understanding what your stakeholders need, and how your organization handles projects.

The scope document is a form of a requirement document which will help you identify the goals for this project. It can also be used as a communication method to other managers and team members to set the appropriate level of expectations.

The project scope management plan is a really important tool in your project. You need to make sure that what you’re delivering matches what you wrote down in the scope statement.

2) Define Tasks: we now need to document all the tasks that are required in implementing and transforming your data to CDISC.

Project Tasks  (Work packages) Estimates (work unit)
Initial data standards review 27
Data Integrity review 17
Create transformation models 35

The work breakdown structure (wbs) provides the foundation for defining work as it relates to project objectives. The scope of work in terms of deliverables and to facilitate communication between the project manager and stakeholders throughout the life of the project. Hence, even though, preliminary at first, it is a key input to other project management processes and deliverables.

3) Project Plan: Once we completed the initiation phase (preliminary estimates), we need to create a project plan assigning resources to project and schedule those tasks. Project schedules can be presented in many ways, including simple lists, bar charts with dates, and network logic diagrams with dates, to name just a few. A sample of the project plan is shown below:

project plan sample

image from Meta‐Xceed paper about CDISC

4) Validation Step: Remember 21 CFR Part 11 compliance for Computer Systems Validation? The risk management effort is not a one-time activity on the project. Uncertainty is directly associated with the change being produced by a project. The following lists some of the tasks that are performed as it pertains to validation.

  • Risk Assessment: Different organizations have different approaches towards validation of programs. This is partly due to varying interpretations of the regulations and also  due to how different managers and organizations function. Assess the level of validation that needs to take place.
  • Test Plan: In accordance with the project plan and, if not, to determine how to address any deviation. Test planning is essential in:  ensuring testing identifies and reveals as many errors as possible and to acceptable levels of quality.

test plan-cdisc

  • Summary Results: This is all the findings documented during testing.

An effective risk management process involves first identifying and defining risk factors that could affect the various stages of the CDISC implementation process as well as specific aspects of the project. riskplan

5) Transformation Specification: Dataset transformation is a process in which a set of source datasets and its variables are changed to  meet new standard requirements. Some changes will occur during this step: For example, variable name must be 8 chars long. The variable label must not be more than 40 chars in length. Combining values from multiple sources (datasets) into on variable.

6) Applying Transformation: This is done according to specification however, this document is active during the duration of a project and can change. There are now many tools available to help with this tasks as it could be time consuming and resource intensive to update the source code (SAS) manually. Transdata, CDISCXpres, SAS CDIDefine-it; just to name a few.

7) Verification Reports: The validation test plan will detail the specific test cases that need to be implemented  to ensure quality of the transformation. For example, a common report is the “Duplicate Variable” report.

8) Special Purpose Domain: CDISC has several special purpose domains: CO (comments), RELREC (related records or relationship between two datasets) and SUPPQUAL (supplemental qualifiers for non-standards variables).

9) Data Definition Documentation: In order to understand what all the variables are and how they are derived, we need a annotation document. This is the document that will be included during data submission. SAS PROC CONTENTS can help in the generation of this type of metadata documentation. The last step in the project plan for CDISC implementation is to generate the documentation in either PDF  or XML format.

CDISC has established data standards to speed-up data review and FDA is now suggesting that soon this will become the norm. Pharmaceuticals, bio-technologies companies and many sponsors within clinical research are now better equipped to improve CDISC implementation.

Need SAS programmers? RA eClinica can help provide resources in-house / off-shore to facilitate FDA review by supporting CDISC mapping, SDTM validation tool, data conversion and CDASH compliant eCRFs.

What Is In A Name Besides Letters?

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Disclaimer: This is based on a fictional story in this fictional world.

Deciding on a name for your company or product is among the first steps an entrepreneur takes. Entrepreneurs often angst over the perfect name for their EDC tool. That name is a break or make deal for many. Your users will either identify with it or completely turn the other way and use your competitor’s EDC system.

It seems straightforward. Who wouldn’t want to stand out?

A rose by any other name is still a rose…

Let’s look at some Mythological names for several {EDC} systems.

  1. Medidata Rave: “Rave” at first thought, it is not an unique name. The traditional meaning of ‘Rave’ was to show signs of madness or delirium (rave. (n.d.). The American Heritage® Dictionary of Idioms by Christine Ammer) but most recent and contemporary meaning is ‘wild party’. For many of us, during the college years, we associated the word ‘Rave’ with underground parties, fun, entertainment and much more. I have been to several White Sensation parties here in Europe. Rave is my favorite name by far.
  2. Cmed Timaeus: Timaeus resonates with ‘Amadeus’. You know, the famous ‘Mozart’, Austrian composer, widely recognized as one of the greatest composers in the history of Western music. If you were born near the 80’s music era then this music video will come to mind.
  3. RDC: In contracts, RDC is “running down” clause, provides coverage for legal liability of either the shipper or the common carrier for claims arising out of collisions. Oracle RDC stands for ‘Remote data capture’. It is easy to remember and catchy.
  4. InForm: Is it ‘information forward’? Information in the form? InForm has been around for several years now. It started becoming popular in the 90s. There has been several modifications and upgrades but the name has stayed the same. It is now part of a group of systems own by Oracle.
  5. OpenClinica: I believe this name refers to the ‘open’ source capability of this tool. Open-source software (OSS) is computer software with its source code made available with a license in which the copyright holder provides the rights to study, change and distribute the software to anyone and for any purpose. (St. Laurent, Andrew M. (2008). Understanding Open Source and Free Software Licensing. O’Reilly Media. p. 4. ). I believe some users may confuse this name with Oracle Clinical, another popular CDM system.
  6. ClinCase: In computer science, CASE tools can be used for simple operations such as routine coding from an appropriately detailed design in a specific programming language, or for more complex tasks such as incorporating an expert system to enforce design rules and eliminate software defects and redundancies before the coding phase. (“CASE”. Encyclopædia Britannica. Encyclopædia Britannica Online). I personally has not used this tool but was asked recently so I added it to the fictious name list.
  7. RedCap: This is a catchy name as well. It can infer many meanings. Cap for capital letters, the cap or ceiling placed on mortgage rates, to protect or to seal? the hat that you wear, a member of the military police. Some further research, wikipedia has the following description of ‘redcap': Redcaps are said to murder travellers who stray into their homes and dye their hats with their victims’ blood (from which they get their name) (Briggs, Katherine M. (1967). The Fairies in English Tradition and Literature. London: University of Chicago Press. p. 57) Regardless of definition, it is still a creative name.

You want a name that your employees and customers will want to say

Should You File For a Trademark? Here is some information about trademarks.

Having a brandable business name is one of the reason for the growth of business. Every EDC system is different and choosing the right name is key on getting the attention your {EDC} tool deserves.

One final reminder. When searching the list of fictitious names (also called “doing business as,” or DBAs) for your county and looking for names in your “class” (or industry) on the U.S. Patent and Trademark Office website (www.uspto.gov), be sure to look up variations on spellings, too, because names that sound alike can’t be registered in the same class. Also check Register.com to see which Internet domain names remain available.

what happens when you find out that your {EDC} name is also the name of another business in a different city/state? Keep it simple, as short as possible (check domain availability) and don’t play too much with spelling alternatives.

What is your favorite {EDC} name? Can a name make or break your chances of business success?

Comments? Join us at {EDC Developer}

Anayansi Gamboa, MPM, an EDC Developer Consultant and clinical programmer for the Pharmaceutical and Biotech industry with more than 13 years of experience.

Available for short-term contracts or ad-hoc requests. See my specialties section (Oracle, SQL Server, EDC Inform, EDC Rave, OpenClinica, SAS and other CDM tools)

 

Credit: The title of this article was an inspiration from a recent readingKate Of Gaia With Michael McCracken – What Is In A Name Besides Letters.” What an eye opening that was.

Fair Use Notice: This blog/article/video contains some copyrighted material whose use has not been authorized by the copyright owners. We believe that this not-for-profit, educational, and/or criticism or commentary use on the Web constitutes a fair use of the copyrighted material (as provided for in section 107 of the US Copyright Law).

If you wish to use this copyrighted material for purposes that go beyond fair use, you must obtain permission from the copyright owner. Fair Use notwithstanding we will immediately comply with any copyright owner who wants their material removed or modified, wants us to link to their website or wants us to add their photo.

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary. If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision.

Disclaimer:De inhoud van deze columns weerspiegelen niet per definitie de mening van {EDC Developer}.

 

 

Are you Practicing GCP?

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You probably heard news or stories such as Misconduct Delayed Drug Approval or Duke Settles Negligence Suit.

The Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki.

The first is to ensure the protection of the patient. The subject’s consent should have been obtained before any study procedure were performed. Each subject is monitor to ensure accuracy and completeness of the data generated.  If an SAE occurred, the monitor will confirm that the SAE has been reported promptly and completely.

The objective of the ICH GCP Guideline is to provide a unified standard practice for the United States, Japan and the European Union (EU) to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

So what are the essential documents during the conduct of a clinical trial?

1- Investigator Brochure documents relevant and current scientific information around the investigation product (IP) has been provided to the investigator.

2- Signed Protocol (including Amendments) and Case Report Forms (CRF) document investigator and sponsor agreements.

3- Informed Consent Form documents the information given to trial subjects.

4- Financial Aspects of the trial documents the financial agreement between the investigator/institution and the sponsor / research for the trial.

5- Signed agreement between involved parties. For example, sponsor and CRO.

6- Institutional Review Board (IRB) / Ethics committee (IEC) documents the trial has been subject to IRB/IEC review and given approval opinion. For example this includes but not limited to protocol and any amendments, CRF (if applicable), informed consent form, subject compensation.

7- Regulatory authority(ies) approval/notification of protocol documents approval/notification by the regulatory authority compliance with the applicable regulatory requirements(s).

8- Curriculum Vitae and/or other relevant document evidencing qualifications of investigator and sub-investigator as document eligibility to conduct trial and/or provide medical supervision of subjects.

9- Normal value(s)/range(s) for medical / laboratory technical procedures documents normal values of the tests.

10- Sample of label(s) attached to investigational product containers document compliance with applicable labeling regulations and appropriateness of instructions to the subjects.

11- Decoding procedures for blinded trials documents how, in case of an emergency, identify of blinded investigational product without breaking the blind for remaining subject’s treatment.

12- Master randomization list documents method for randomization of trial population.

13- Pre-trial monitoring report documents the site is suitable for the trial.

Note: Any or all documents listed in this guidelines may be subject to, and should be available for audit by the sponsor’s auditor and inspection by the regulatory authority(ies). Any revision to any of the above documents should be added to the files during the trial as evidence.

After completion of a trial, some other documents such as completed subject identification code list, audit certificate, clinical study report and final trial close-out monitoring report shall be available to document completion of the trial.

Research and practice may be carried on together when research is designed to evaluate the safety and efficacy of a therapy. Basic Ethical principles refers to those general judgements that serve as a basic justification for the many particular ethical evaluation of human actions. Respect for persons where persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well being.

Do not harm – hippocratic maxim

 Who ought to receive the benefits of research and bear its burdens?

An injustice occurs when some benefit to which a person is entitled to or when ought to be treated equally. This principle applies to the rights, safety and well-being of the trial subjects with most considerations and should prevail over interests of science and society.

Conducting clinical trials, in accordance with this principles of good clinical practice (GCP), makes it possible to test the effectiveness and safety of medicines, hence, it is important the understand the principles established in the guidelines.

Source:

http://www.ich.org/home.html and http://www.the-scientist.com/

Anayansi is an EDC Developer Consultant and clinical programmer for the Pharmaceutical and Biotech industry with more than 13 years of experience.

Available for short-term contracts or ad-hoc requests. See my specialties section (Oracle, SQL Server, EDC Inform, EDC Rave, OpenClinica, SAS and other CDM tools)

Fair Use Notice: This blog/article/video contains some copyrighted material whose use has not been authorized by the copyright owners. We believe that this not-for-profit, educational, and/or criticism or commentary use on the Web constitutes a fair use of the copyrighted material (as provided for in section 107 of the US Copyright Law).

If you wish to use this copyrighted material for purposes that go beyond fair use, you must obtain permission from the copyright owner. Fair Use notwithstanding we will immediately comply with any copyright owner who wants their material removed or modified, wants us to link to their website or wants us to add their photo.

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary. If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision.

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