Sagi, Life Sciences Information Technology and eClinical Professional

Oracle's Drug Development and Safety Forum 2008

2008-09-03T16:37:00.002+05:30

Oracle's Drug Development and Safety Forum 2008
September 18 - 19, 2008
Golden Palms Hotel & Spa, Bangalore

Oracle invites you to the 2008 Drug Development and Safety Forum

At this forum we will be discussing important topics and issues facing the Indian Pharmaceutical, Biotechnology, and CRO industry. The event will be highlighted by presentations from key industry thought leaders who will share their perspective on industry best practices as well as their unique experiences.

The content will cover important topics in clinical development, and safety. You will hear how Oracle solutions have enabled organizations in the industry shorten their time to market, gain operational efficiencies, reduce clinical study costs and accelerate insight into action.

As a follow up to the success of last year's Oracle Life Sciences Applications User Group Oracle's Drug Development and Safety Forum will prove to be a must attend event.

Register, at this link or e-mail your registration details to kelly.yeo@oracle.com (include your name, company, e-mail address, contact mobile number, arrival/departure - dates/time with flight details and mode of payment).

Early Bird Registration
Register by Thursday 11 September for the discount rate of Rs.5950 per delegate, all payments paid to Golden Palms Spa.

September 18 - 19, 2008

Golden Palms Hotel & Spa
Golden Palms Avenue,
Hobli, Tumkur Road, Bangalore
Karnataka, India

Reservations can be made by calling Golden Palms Hotel & Spa at +91 - 080 - 23712222.
Golden Palms Hotel & Spa

Keynote and Industry Presenters:

September 18 Ranbaxy, Siro Clinpharm, HCL
September 19 Institute of Clinical Research India, Panacea Biotec, PharmaSol,
CliniRx, Quntiles, Cognizant

Agenda at a Glance

Thursday September 18
1:30 PM
Registration
3:00 - 3:45 PM
Oracle Clinical Development and Safety
Vision and Strategy
3:45 - 6:00 PM
Keynote Presentations by Ranbaxy, Siro Clinpharm and HCL
7:30 PM
Networking Cocktail Reception and Dinner

Friday September 19
8:30 AM
Institute of Clinical Research India Keynote
9:40 AM
Oracle Clinical Development and Safety Solutions
10:40 AM
Oracle Solutions for Clinical Operations and Project Management and Case Study
11:30 PM
Panacea Biotec Keynote
12:00 PM
Oracle Global Support and Customer Care
12:20 PM
Networking Lunch
1:20 PM
Oracle Solution for Clinical Data Management and Electronic Data Capture and Case Study
2:30 PM
Oracle Solutions for Safety and Pharmacovigilance and Case Study
3:20 PM
Cognizant Keynote Presentation
4:00 PM
Adjournment

Oracle announces Oracle Health Sciences Global Business Unit (HSGBU)

2008-08-12T14:18:00.004+05:30

During DIA 44th annual meeting held in Boston 23 June 2008, Oracle announced creation of its new Health Sciences Global Business Unit (HSGBU). This new organization within Oracle will help Life Sciences and Healthcare companies accelerate insights for better health. It will build on Oracle's proven track record in the sector. Today, 20 of the 20 top pharmas and 14 of the 15 top U.S. hospitals run Oracle applications.

Complete press release can be accessed here -
Oracle Health Sciences press release

DIA India Conference 2007: Drug Discovery & Clinical Development

2007-12-07T15:49:00.000+05:30

'Invite all USA citizens to live in India as there are no ADRs in India' By Dr Pipasha, Head Symogen

'To undertand the culture of a country, look at the 100 best commercials of that country' By Prahlad Kakkar, Well known Adfilm Maker

'In India, decision of a women participating in a clinical trial is taken by the head of the family' Dr Narges, VP, Quintiles India

'In Mynamar, ADR has to be reported in police station' By Dr Vivek Ahuja, Ranbaxy

'Pharmacovigilence is happening, come and join' By Dr Pipasha, Head Symogen

These are some of the well received comments/statements from the expert speakers of 2nd Annual conference of DIA India(Drug Information Association) which was held in Mumbai Renaissance Hotel during 18th to 21st November 2007. I think, this is the only conference in India where DCGI participates (similarly, FDA participates in US DIA). Conference was very informative both from the industry and academics point of view. Got a chance to meet my industry friends/customers/prospects like Arjun roy (Ranbaxy), Aranee (Panacea), Nagendran (Karle), Suresh Ramu (Quintiles), Arun Bhat (ClinInvent), Umakanth Sahoo(Chiltern), Ashwin Mathur (Novartis), Gagandeep (CTS) etc and could discuss about happenings in their lifes and trends in the industry.

Day2 (Day1 was full of tutorials), Monday Nov 19th, started with a keynote address about opportunites in Canada by Supriya Sharma, Acting Director General, Therapeutic Products Directorate, Health Canada.

Day3 was full of presentations on clinical research and pharmacovigilence.
Dr Narges (Quintiles) gave a very good message about how clutural factors determine conducting clinical trials in India and how Quintlies addressing those issues.

Prahlad Kakkar, well known adfilm maker, spoke about why researchers should care about Indian culture, dreams of middle income man etc. He also, spoke about rural dreams vs urban dreams, Liril soap advertisement and the sensation it created in early 90's among rural women.

He also, showed top ten TV commercials that were made by him in the recent past including very popular Sachin Tendulkar's Pepsi and HappyDent white.

Sachin Tendulkar's Mask Pepsi TV commercial:

In the afternoons Pharmacovigilence (PV) parallel session, Dr Pipasha (Symogen) spoke about her current affairs with DCGI and other Indian PV authorities and lack of awareness in India about PV.

Dr.Vivek Ahuja of Ranbaxy spoke about Ranbaxy's PV initiatives, ADR reporting requirements in Peru and Mynamar. Dr Moin Don (Reliance) questioned why in India PSURs have to be submitted only for 4 years why not for the entire duration?

Steve Hussey (PRTM consulting) spoke about India's current competition from China in the clinical trials outsourcing space.

John Wise (Daichi Sankyo) spoke about how softwares evolved in the clinical data management space with emphasis to Oracle Clinical product.

Dr Arun Bhat (ClinInvent) spoke about strategies for Investigator training and enhancing startegies for supply and demand ratio.

Dr Kiran Marthak (Veeda) spoke about different outsourcing models that can be applied to clinical research in India.

Dr Bhargava (CCMB) gave a very thought provoking speach on how the healthcare/life sciences landscape will change and what kind of scientific advancements will be visible in the next 40 years from now.

Some more photographs:
Kamlesh Patel from CliniRx..

Event organiser, Manjo Tiwari (Biomed) in a lighter moment with Prhlad kakkar

Me with Manoj and others

Dr Pipasha disussing a point with Prahlad..

Dr Nagendran, Head of Clinical Research Karle group..

Preeta from GSK and other deligates

Team from SIRO ..

Me again with Manoj and others..

Stalls setup during the conference..

Conference agenda, Presentations, and more photographs can be found on the conference website Biomed Consluting India

Oracle Life Sciences Applications User Group (OLSA UG) India: 1st Annual Conference

2007-11-26T15:11:00.000+05:30

Oracle Life Sciences Applications (OLSA) India team organized for the first time a two day conference for its Indian customers of Oracle Life Science Applications at Golden Palms Resort and Spa located in Bangalore on 26th and 27th Oct 2007. The purpose of this meeting was to bring various stake holders of OLS Applications like users, partners, prospects and Oracle and provide a platform to share experiences, ideas and solutions within the user community to facilitate exchange of information.

The first day of the conference started at 12 noon which included an introduction of Oracle and OLS Application group and its presence in India along with presentations and demo on Oracle LS applications and the future plan for the products.

I presented a live working demo of new zero foot print 4.5.3 version of RDC (Remote Data Capture). The day ended with interactions, networking and discussions over drinks and dinner at the pool side of the resort.

Day two started early morning with presentations from our customers and partners on general topics as well as their experience on the applications and how they have improved their performance with the help of the OLS applications. Some of our partners presented their experience and how they have provided added value to their customers by integrating various applications at their premises.

During post lunch session, I again presented RDC 4.5.3 demo to the attendees (had to repeat due to some conference projector issues on the day one).

The conference ended with a discussion on formation of the India User group, which can potentially be collaborated with the OCUG.

Conference website
Conference photo albums on picasa

Have any questions about any of the OLSA products, do write to me or post it in OLSA UG India discussion forum

Practicing CDISC SDTM – A Quick Review

2007-11-26T11:17:00.000+05:30

This article was written by me during Jan/Feb 2006. It was reviewed by OCUG eXtra newsletter publishing committee, accepted and published in Mar 2006 eXtra. Link to the article (some how it doesn't seem to work): http://www.profmgmt.com/newsletter/OCUGNews0306.html

Full article:
What is SDTM?:
SDTM defines a standard structure for study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA). The Submission Data Standards team of CDISC defines SDTM. More information and to download documents http://www.cdisc.org/

Why should I worry about SDTM?:
On July 21, 2004, the SDTM was announced as the standard specification for submitting tabulation data to the FDA. Eventually, all data submissions will be expected to conform to this format. As a result, Clinical Data Managers will need to become proficient in the SDTM to prepare submissions and apply the SDTM structures, where appropriate, for operational data management. FDA guidance available at http://www.fda.gov/cder/regulatory/ersr/Studydata-v1.1.pdf

What challenges sponsor \ my company will face when preparing for SDTM?:
Following are some of the challenges sponsors will face when preparing to submit data in SDTM format.
Use SDTM variable names: Sponsors may not add new columns to SDTM datasets. Validation tools at the FDA will check datasets for compliance upon receipt, and sponsors may eventually be asked to re-submit data that does not conform to the SDTM rules.
Use the defined structures of the SDTM: Sponsors may not submit alternative structures. The largest impact of this will be felt with findings-type data (e.g., planned measurements such as vital signs and questionnaires).
Non-standard columns can only be submitted as rows in either the SUPPQUAL dataset or as additional rows of a Findings dataset: Challenge here is to decide which observation class this kind of data fits in to. For e.g., It is logical to model a spontaneous occurrence like hospitalization in to an SDTM Event.
Relationships between independent records should be documented using the RELREC dataset rather than via internal foreign keys: For e.g., for a spontaneous occurrence like hospitalization, one row describing the adverse-event record (cause of hospitalization), and one describing the hospitalization record.
Preparing and Submitting Trial Design Tables: These tables are designed to describe planned and actual treatment and visit information. The trial-level tables (Trial Elements, Trial Arms, and Trial Visits) represent plans for the study. The subject tables (Subject Elements and Subject Visits), on the other hand, represent what actually happened for each subject.

Where does SDTM implementation fit in my company’s process?:
There are a number of possible places within a company’s processes where the changes needed to produce SDTM-compliant datasets could be implemented. The decision of where to implement will also depend upon other factors including:
Will the CDMS allow use of eight-character names and maintain the necessary functionality?
How many SDTM variables can be directly mapped to CDMS fields?
How will data collected using legacy standards be integrated with those collected using SDTM standards?
How flexible does a sponsor need to be in terms of choosing datasets to be submitted using legacy standards versus those using SDTM standards?
How many submissions are expected each year? Larger numbers may tend to favor more up-front investment, while smaller numbers may favor a more individualized approach.

How does one can attempt to make CDISC compatible studies using CDMS?:
Following are few guidelines that can be followed for this purpose:
- Build implementation team(s), Receive CDISC training, Collect information
- Learn how to transform CRF information into CDISC data models
- Implementation strategy could be a “Hybrid System”. All objects that are easy to define or derive in CDMS are set up in the database. Further transformation and additional items are done in SAS
- Set up Global Library domains containing CDISC questions for the classes: Interventions, Findings, Events
User experience indicates that, in a standard CDMS application, about 70% of the objects can be directly defined or derived in the database, where as the reminder is easily identifiable as non-CDISC items and must be appropriately processed after extract into SAS.

What should I do if I think that a variable I need has been left out of the SDTM?:

First, determine whether this is a variable that is usually collected by the pharmaceutical industry. If so, then you may request that the SDS Team consider adding it to SDTM through the CDISC Discussion Forum. If SDS Team decides that the variable is not likely to be widely used by others, then it should be submitted as a row in the SUPPQUAL dataset.

Emerging Trends in EDC: Integration of EDC with eSource from EHR systems at sites

2007-11-11T14:58:00.000+05:30

This article is reviewed, accepted and due for publication in 2008 by expresspharmapulse magazine.

The adoption of electronic medical records (EMRs) in both hospitals and private practice is on a steady incline. Alongside the growth in EMR, EDC systems are today used in an estimated 30-35% of clinical trials, again in both hospitals and private practices. The use of electronic data capture technologies provides the opportunity to significantly enhance clinical trial conduct through improved efficiency and accuracy as well as the potential for real-time response to possible adverse situations. The data captured in clinical trial systems may be based upon a prior electronic source (eSource), such as EMR. Unfortunately, many of the EMR systems that manage the electronic source today cannot be used reliably for clinical research purposes because of the variability among these systems and the fact that they are not required to meet regulatory requirements for clinical trials. Therefore the data that are in the EMR system have to be printed or hand-transcribed and re-entered into the EDC system. The duplication of tasks, generation of paper and associated costs and inefficiencies, will only grow with the increasing use of electronic data sources. With the transformation in healthcare data collection migrating from a paper world to EDC one, the scenario begs the question, “How EDC can integrate with these systems at sites and avoid redundant data collection?”

The eClinical Forum (www.eclinicalforum.com) and PhRMA EDC/eSource taskforce is very much active in formulating standards around integrating aspects of clinical trial data with healthcare data. This article has reference to many of the survey work and visionary publications of these groups.

EDC background

EDC is a technique for collecting clinical trial data in such a way that they are delivered to the sponsor in electronic form instead of paper. This includes the following scenarios:

· Information that is first recorded on paper by the investigator’s staff or the patient, is subsequently entered into a computer at the investigator’s site, and is delivered electronically to the sponsor or sponsor’s representative (such as a CRO) without a hand-written case report form. The computerized system into which the site enters the clinical trial data is generally provided and maintained by the sponsor or a third-party vendor.
· Clinical laboratory data that are transmitted to the sponsor electronically and batch-loaded into the sponsor’s database (includes other electronic data such as device data)
· Patient data that are directly captured by instrumentation
· Electronic patient reported outcome (ePRO) i.e., information that is entered by the patient directly into an electronic device, such as personal digital assistant (PDA), or directly into a web-based system
· Information that is entered by the investigator’s staff directly into a computer, without first writing the data on paper (i.e., electronic source (eSource) data) and which must then be backfilled to the patient’s permanent record (paper or EMR) in order to satisfy regulatory obligations.

The use of electronic data capture (EDC) by the bio-pharmaceutical industry to conduct prospective clinical trials on new drug candidates is growing as bio-pharmaceutical companies face increasing pressure to bring new, innovative products to market faster and in a more cost-conscious manner than ever before. At the same time, increasing concern over product safety has resulted in the need for more and longer trials, causing costs and time-to-market to increase. The use of EDC is seen as a way to improve data quality and drive efficiency in the clinical research process.

eSource Background

The capture of patient data into electronic systems, initially used for patient care purposes, is emerging and has great potential to be a source of data for clinical trials, enabling automated transfer. Today, there are a number of interchangeable terms used to describe such systems. The terms Electronic Health Record (EHR), Electronic Medical Record (EMR), Electronic Patient Record (EPR), Clinical Patient Record (CPR) and Lifetime Clinical Record (LCR) are all used by various individuals and organizations, at times to mean the same thing and at other times to mean different things. In the remainder of this article, the term Electronic Health Record (EHR) will mean eSource data captured in a format that enables structured electronic transfer to clinical research systems. Using this definition, other eSource data commonplace today such as electronic patient reported outcomes (ePRO) and central laboratory data are not considered parts of EHR data, as these data are not captured within the EHR initially, although they could be integrated with it subsequently.

The vision: EHR/EDC integrated system

The existing “transitional” or “emerging” environment of EHR and EDC systems both being used in an investigator’s office may at times seem like a step backward. For multiple reasons, the same data is being entered and maintained in up to three or four different places. Healthcare practices may first involve a process in which the provider hand-writes information on a patient chart which is then entered into their EHR system at a different time. This same information may be printed off the EHR system and transcribed for entry into the EDC system. At the end of the study, regulations require that the data in the EDC system remain with the investigator, so it is often printed or copied to CD for inclusion with the patient’s medical information.

Collaboration between these two worlds may work as follows:

· Pharmaceutical company designs and deploys study at the site using a clinical data management/electronic data capture solution (possibly vendor provided). This solution has an in-built module that employs standard interface definitions developed by a standard committee within bi-pharmaceutical community and healthcare industries. Using the standard interface definitions, the clinical module can be recognized by any certified electronic health record (EHR) system being used by the investigator sites.
· When a patient comes into the practice, the investigator staff will have access to the patient’s entire history, regardless of where the care was given. Any third party diagnostic parameters (such as lab test or x-ray results, patient diary data) will also have been received and stored in the EHR system such that is readily available to the investigator. The staff will enter all information pertinent to this patient visit. Additional information and screens will be displayed (related to clinical trials) to prompt the staff to collect the additional information and to assist with scheduling and patient visit reminders.
· The clinical trial patient data will physically reside in both the EHR system and the sponsor’s analysis database. Only the EHR system’s clinical data module will be considered the source, and it must stay in a validated state under the control of the investigator. Security features surround this module such that it is in compliance with all regulations pertaining to clinical data.
· At the end of the study, data from this module will be archived in a standard format (perhaps XML or PDF) such that it can be easily read by the investigator and/or an auditor in the future, using standard tools, if need be.

Why It’s Necessary To Merge These Worlds

Benefits of EDC studies (improved data quality, time-to-market, resource efficiency) could be seen by 100%:
Currently adopted in about 27 to 30 percent of clinical trials, EDC provides acknowledged benefits over paper CRF data capture. Since a significant portion of the clinical data (e.g., medical history, medical procedures, prescribed medications, vital signs) needed for the trial will already be available in an electronic form through the EHR, the introduction of the clinical research processes in EHR systems and processes will extend and accelerate the existing benefits of EDC into an increasing number of clinical trials and an increasing number of hospitals and healthcare clinics.

Clinical trials available to more physicians:
Additionally, more physicians could become involved in clinical research barring one major hurdle to participation that would be eliminated if, clinical data capture were to be straightforward and readily available for those facilities that have adopted EHR systems that include EHR/EDC technology.

Avoid duplicate tasks that increase cost of clinical research (thus increasing costs for marketed medications):
Significant benefits can be accrued through collaboration of both the healthcare and research worlds by effectively and efficiently sharing data. Without such collaboration and as the use of EHRs grows, both the healthcare sector and bio-pharmaceutical companies will be obliged to spend valuable resources on duplicate tasks, increasing the overall cost of clinical research and its product.

Benefits to Patients:
All patients whose healthcare provider participates in a nationwide EHR system will reap benefits of that system facilitating clinical research. These benefits are:
· Potential to address underserved populations through clinical trial recruitment and participation
· Greater possibility of being identified for a clinical trial because their physician will have better ability to search his/her patient population for inclusion criteria
· New therapies get to market and reach patients faster due to more efficient clinical research process
· Higher data quality leads to better safety

Benefits to Investigator staff:
· Patient recruitment – EHR records could be searched for patients satisfying inclusion/exclusion criteria. The assumption is that EHR systems will have the capability to define criteria for selection of patients (e.g., disease, severity, medications taken, medical history, and specific vital signs such as blood pressure)
· The time required to check-in a patient and complete the medical record will be significantly reduced:
· Data entry will be simplified and more efficient due to a one-time data entry into the EHR system (instead of today’s multiple entries) and improved record retrieval
· Direct transfer of validated data to research systems will be simplified and more efficient due to a common validated interface
· Information storage will be more efficient as data will be stored electronically saving on space requirements currently needed for paper trials and/or multiple trial/sponsor hardware
· Serious adverse event (SAE) reporting and management may be simplified and improved as SAEs and associated relevant information, maintained within the EHR could be sent to the sponsor. The sponsor could have the capability to obtain information pertinent to the outcome and causality of the SAE by having real time ongoing access specific to the SAE enabling them to prepare a comprehensive narrative.
· Regulations and controls surrounding clinical data capture can improve overall quality of all data managed by the EHR system
· Potential to perform more trials with same level of in-house resource due to efficiency in trial management
· Investigators will access their data through the use of a single and familiar EHR rather than through different sponsor/vendor developed front-ends, reducing training and ongoing support issues
· Efficiency in presentation of patients’ entire medical history, including data from clinical trial participation
· Standards will enable data collection and integration to be more consistent and investigators will have a common understanding with regard to data definitions and format when dealing with multiple sponsors

Benefits to Regulatory authorities:
· With a nationwide network, regulatory authorities could have the capability to review and audit sites’ electronic source data against the data provided by the sponsor, thus reducing need for actual site visits by auditors while giving more transparency to the authorities
· Refocus workload – the reduction of paperwork will allow for auditors to focus more on areas
· Facilitated audit trail – standard audit trail information for review with a submission

Benefits to Sponsor / Bio-pharmaceutical Industry:
· With the ability to compare safety data from a clinical trial to a much larger baseline (i.e. all EHR patients), there is a potential for improved analysis and projection of long-term safety. This can be accomplished through the sponsor’s ability to do large retrospective trials to identify potential safety issues or review post-market product use, via access to information on patients who are using these products. Such retrospective trials would need to be in compliance with patient privacy regulations. New regulations may be required to address how aggregate data can be accessed and by whom.
· Better access to target patient populations
· Ease of study execution:
o Utilization of standardized EHR/EDC components
o As data transferred to research is a transaction copy of the source data no source data verification (SDV) will be required and queries will be reduced
· Eliminates redundant computer systems and overhead:
o Application and hardware support, helpdesk, and training will be reduced
· Archiving requirements will be significantly reduced:
o More of the Trial Master File will be electronic
o Sites will already hold research data (as source) therefore preparation of an archive copy for retention at the site may not be required
· Pharmacy and patient records will be integrated within the EHR environment allowing drug accountability to be performed electronically via electronic access to dispensing and usage, monitoring of supplies, automated ordering, etc. Randomization to treatment would be handled external to the EHR
· Transcription errors are reduced or eliminated
· EHR/EDC will lead to improved efficiencies with regard to time saving and can contribute to reduced cost in clinical trial execution. This will be achieved through elimination of redundant processes
· Collect data in a format that lends itself to integration for submission
· Potential to reference data, required supporting the clinical research, maintained and stored on the EHR rather than duplicating it in the sponsor’s database (e.g., medical history, prior medication and procedures). Data necessary to prove efficacy and safety would still exist within the sponsor’s submission datasets as well as the EHR.
· Potential investigator list is expanded to include any physician with a certified EHR/EDC system.

Conclusion: Impact on Data Management

What do you need to do as a Data Manager/CRA/Programmer/QA personal to prepare for the future of data management?

Education and involvement! You need to educate yourself on what is going on in industry by attending conferences, webinars and other training sessions to learn about what is changing, developing and going out to pasture. Look outside of the usual data management box to see the other potential influences on the profession.

Following is an analysis about potential change / impact on the current clinical research roles and responsibilities that may evolve because of EHR/EDC integration -

1. Roles & responsibilities in all areas will evolve:
· Clinical Research Associate (CRA): The traditional work of the CRA will migrate into more of a site relationship management role. The EHR/EDC system removes the need for much of the CRA's time to be spent checking and managing paper CRFs allowing time on-site to be spent more effectively providing protocol and safety training, ensuring GCP compliance, etc. More complex interrogation of the EHR may allow the detection of omitted information such as non-compliance with exclusion criteria, non-reporting of prohibited concomitant medications, etc.
· Data Manager: This role changes to be far more site oriented, as data managers become the liaison between the data and the site staff communicating primarily via the EHR/EDC system. Preparation of ongoing reports for safety and review purposes and programming of extraction algorithms may move this toward a more technical role. New tasks might involve transferring research data back to EHR (e.g., laboratory data). In addition, Data Managers will have more involvement in protocol development as data definitions will need to be built into the protocol to assist ethics committees/IRBs in reviewing data collection requirements and to enable the development trial-specific EHR modules.
· Information Technology (IT) Support Personnel: IT staff will need to be more aware of the total process of clinical trials from eSource through submissions. They will need to be more involved in defining the study protocol, as it will additionally need to specify electronic methods of data collection and identify electronic source.
· Quality Assurance: QA must audit EHR/EDC systems to ensure appropriate controls exist such that investigators can be accountable for the integrity of the data (eSource) they provide.
2. The informed consent process will change. This will include all that are involved in the process (e.g., sponsor, site, patients and IRB/ethics committees):
· Data is moving to patient ownership. The informed consent documentation will need to be adapted to collect patient approval for clinical trial participation
· Informed consent can be given electronically
3. Some cost may be shifted due to a shift in some responsibilities for activities such as data hosting, on-site validation (data/system), trial module development/configuration
4. Review of data for fraud will change:
· Fraudulent data will likely be reduced (never eliminated) as sponsors will be able to monitor the timeliness of the data entry and any changes
· Since the EHR is usually accessible to many medical and nursing staff, it is less vulnerable to fraudulent changes by an individual
· The sponsor will look for data trends, in order to detect fraud

So what’s at stake here? It’s the time to re-establish the value proposition for data management / EDC within your organization. You can choose to take an active role, or to let it happen to you. Actively clarify your goals to reduce stress, focus energies, simplify decisions and prepare for success. Forward-thinking data managers will continue to be invaluable contributors in the growth and success of clinical research. Be one of them and be ready for the next generation of Electronic Data Capture!