oracle clinical and rdc implementation standards and best practices

Oracle Clinical / Remote Data

Capture Implementation Standards

and Best Practices

Lori Venable

Thank you for joining. We will begin shortly.

Welcome & Introduction

Lori Venable Principal Consultant

• 23+ years of experience in the clinical trials industry

• 15+ years of experience with Oracle Clinical and Remote Data Capture (RDC)

Today’s Agenda

Time Topic

10:00-10:05 Welcome and Introduction

10:05-10:10 Who, What and Why?

10:10-10:20 Common Themes

10:20-10:25 Training

10:25-10:30 User Roles and Functions

10:30-10:35 SOPs and WINs

10:35-10:45 Implementation and Usage Standards

10:45-11:00 Q&A

Who, What and Why?

• Who is the intended audience?

– Non-OC/RDC Users evaluating the

application

– New users of OC/RDC who are defining

their implementation standards, SOPs,

WINs, etc.

– Current OC/RDC Users contemplating an

upgrade to newer version and/or

modifications to existing practices

• What is a Best Practice? A method, process, activity, incentive, or reward that is believed

to be more effective at delivering a particular outcome than any other technique, method, process, etc. when applied to a particular condition or circumstance.

en.wikipedia.org/wiki/Best_practice

A way or method of accomplishing a business function or process that is considered to be superior to all other known methods.

www.qaproject.org/methods/resglossary

A best practice is a business process with demonstrated ability to achieve superior results. Best practices represent proven methodologies for consistently and effectively achieving a business objective.

www.hrsdc.gc.ca/eng/workplaceskills/oles/2009/glossary

Who, What and Why?

Who, What and Why?

• Why are standards important?

– In order to really capitalize on the functionality within OC/RDC, standards are critical

– Standardization helps minimize study setup time immensely – reusability of standard objects, processes, etc.

– Increase in efficiency

– Increase in quality

– Increase in productivity

– Decrease in time and money

Common Themes …

• Teamwork

– Right level of inclusion

– Cross-functional partnership

– Recognize contributions and needs of ALL

members

– Communication

– Buy-in from all team members

– Active participation

– Are there global needs?

– Benefits for proper level of team involvement are phenomenal

Common Themes

• Standards … standards … standards

– Increase ease and speed of use for OC/RDC

– Increase efficiency and productivity

• Process Improvement

– Continuous

– Debriefing after all projects

– Receptivity

– DON’T BE AFRAID to change!

• Use your resources!

Training …

• Application(s) … OC / RDC

– Formal training … e.g., BioPharm

– Right level of ‘inclusion’

– Hands-on users vs one-off users vs mgmt

– Delivery method

– Instructor-led (onsite vs public)

– Online web-based

– Hands-on exercises

– Internal ‘train the trainer’

– Consistent material

… cont…

Training …

• Application(s) … (cont…)

– “Just-in-Time” training

– Not too early

– Plan ‘play’/practice time in training environment

– Pilot study(ies)

– What study(ies) to use

– Helps in making decisions and planning standard

processes

– Self education …

– LOTs of resources available

– Learn from your mistakes (you WILL make

some!)

• Processes

– Assess current processes and future needs

– Formal and informal

– Internal and/or external (e.g, BioPharm)

– SOPs / WINs

– Process Improvements

Training …

• Other training considerations

– Cross-functional education & understanding

– The “whats” and “whys”

– Ongoing

– Retraining

– Certification / proof of training

Training

User Roles and Functions

• Clearly outline all needed roles/ functions

• Current resource availability

• Company size

• Internal vs external resources

• User account creation and maintenance

– Pre-requisites

• Other considerations

– Frequency of some tasks

Standard Operating Procedures…

Best Practices:

SOPs should be very high-level, with minimal detail – the overview of “WHAT” we do

Begin to draft SOPs during the training and pilot(s)

Right level of inclusion

Train users on the SOPs as part as part of system training

Recommended: 6-12 SOPs for OC/RDC

SOPs associated with OC/RDC typically include information

about the setup and use of the application(s) in conjunction with

the day-to-day collection and management of clinical trial data.

• Review and assess current SOPs and business processes

– Identify gaps and requirements gathering

• Consider other departments

– Overlaps? … gaps? … inconsistencies?

• SOPs are subject to audit

– Do not reference other documents in SOPs

• Ideal: finalize before “go live”

– Reality: not quite ready

– Document … document … document

SOPs

Work Instructions (WINs) …

Best Practices:

WINs should be more detailed … the “HOW” we do it

Develop WINs concurrently with SOPs

Right level of inclusion

Train users on the WINs as part as part of system training

Each SOP should have at least one supplemental WIN (generally 1-7 WINs per SOP)

Work Instructions provide detailed steps on how to perform a specific task or function in OC/RDC

• Supplement the SOPs with the detailed step-by-step “HOW TO”

• Supplement to training

• Review and assess current processes

– Identify gaps and requirements gathering

• Consider other departments

– Overlaps? … gaps? … inconsistencies?

WINs …

• WINs are not subject to audit

– Freely reference other documents/sources

• Attachments common

– Checklists, quick reference guides, etc.

• Less formal than SOPs

– Still need inclusion, review, finalization, etc

– Easier to update/modify

• Ideal: finalize before “go live”

– Reality: still in development

WINs

• OC / RDC implementation is most successful with strong commitment to standards

• 80/20 rule

– Protocols, CRFs, edit checks, cross-study

consistencies, etc.

– OC/RDC implementation standards

• But … recognize need for flexibility

– Communicate the “costs” of deviations from

standards

– May need to challenge some requests

Implementation and Usage Standards …

• Maintenance of standards

– CRFs, OC objects, DMP, SOPs, WINs, training

materials, processes, other resources/tools

– Everyone’s responsibility

• Process Improvement (again! )

– Openness to change

– “Think outside the box”

Implementation and Usage Standards

Summary

• Keep in mind our common themes:

– It’s all a team effort

– Communication

– Standards … standards … standards

– Process Improvement … ongoing, continuous

– Don’t be afraid to make mistakes … be open

to learning from them

– Take advantage of all the resources you have

at your disposal

Q&A

Closing

Thank you for attending!

This webinar will be posted on www.biopharm.com

within 24 hours

Contact BioPharm Systems

United States: +1 877 654 0033 EMEA: +44 (0) 1865 910200

Email Address: info@biopharm.com

(also Vicky Green: vgreen@biopharm.com)