ProCDM SOP program; the package to complete, every clinical data management SOP you need! A 6 weeks team program to approved standard operating procedures.
Do you need to create new SOPs or update SOPs and
- does that look like a huge mountain rather than an exciting challenge?
- are you looking for a plan to take you through?
With ProCDM SOP program; the package to complete, every clinical data management SOP you need, you'll have a way to look forward to your new SOPs, to enjoy your team's knowledge and skills and to stick to the plan.
Why do you need enthusiasm, your team and a plan for SOPs?
Maybe you recognize this; SOP creation or updating is done at intervals. SOP writing skills faded when the next SOP round is to start. If you don't do this regularly, or following a plan, it is difficult to cover all SOP aspects. I've felt insecure myself about my first SOPs and first sets of SOPs. Were they specific enough? Did they comply with applicable regulatory requirements? At that time; requirements for drugs, devices and biologics! Did I capture every aspect of the process in procedures? Wasn't I forgotten something? Is it wise to split a large process in two SOPs? Is the SOP easy to read and easy to follow for new team members?
And of course, it had to be done when other milestones, of ongoing clinical study projects, also had to be met.
I worked as data manager. And although I handled a number of data management systems, I did not handle all. Thus I can not create SOPs for you without knowing the data management system you work with, your data logistics, functions, tasks... That's why the content details come from you. You can create your SOPs as detailed as you need them.
And you will insert the unique YOU of your organization in to the visuals and the text.
Important for me is that it won't become a never ending project, wasting time and energy.
Thus this SOP program. Solid and quick. Plan(ning) and materials ready to use. 6 weeks full speed ahead with the team, next to the members' normal tasks. Each one contributing more knowledge, skills and ... than thought to be possible.
And after 6 weeks? Plenty of room for other projects!
SOPs are an inevitable contribution to sound business and regulatory compliance. But it could be more fun, more compact, and a valuable team-effort.
The most considerate problems with the creation of SOPs are:
- faded SOP creation experience and skills,
- not sure from a regulatory perspective WHAT needs to be in there and WHY,
- competing other tasks, like clinical study deadlines,
- lacking a plan with inititation meeting results, time for valuable procedure discussion and distribution of tasks
- lacking a 6 (max.) weeks schedule.
Does it have to be this way? You and your team can have a great time while creating or updating SOPs.
You too can:
- get a set of questions to help you creating each SOP,
- get a SOP template and a User Manual template to work with,
- propose and get a team approach to draw your organization's backbone,
- get confident about your final SOPs,
- enjoy creating or updating SOPs,
- benefit from the team's knowledge and experience,
- include review and SOP training within the project,
- improve your SOP creation method,
- achieve this within 6 weeks.
What do you need to achieve this?
1. A plan.
A program to repeat for future SOP creation rounds.
2. Follow-up.
To check progress, solve obstacles and improve your program.
3. Support to carry out the plan.
Material like a SOP template, a Start meeting invitation & agenda, a SOP feedback & training meeting schedule, questions to help you complete your SOP text, a how to capture an actual procedure in a flowchart guide, timeliness setting, and workday inspiration to start, progress and complete during 6 weeks.
You can create SOPs within 6 weeks too, with ProCDM SOP program; the package to complete, every clinical data management SOP you need.
You'll get:
The e-book ProCDM SOP program; the package to complete, every clinical data management SOP you need. Pre-view the content here>
But more important, you and your team get dosed material for direct use according to the 6 weeks schedule. Amongst others a SOP template with questions to answer, a User Manual template, the planning with timeline setting, meeting invitations & agenda's, regulatory background information, flowchart creation and much, much more valuable material during the program to get your new SOPs up & running within 6 weeks.
Bonus for clinical data management: 8 clinical data management SOPs, including computerized system validation. Over 3000 euro value when you are setting up a clinical data management organization.
You'll need:
-
to have MsOffice (MsWord, MsExcel and MsPowerpoint) or compatible software up & running to benefit from the bonus material,
- to have applicable laws and guidances available for reference, (An overview of applicable laws and guidances in clinical research, and for CDM in particular>)
- to pro-actively prepare, pick tasks, complete the timeline setting and conduct.
The ProCDM SOP program; the package to complete, every clinical data management SOP you need costs € 2468 excluding VAT to help you to get new SOPs up & running within 6 weeks.
Order this program by contacting ProCDM via http://www.procdm.nl/pages/contact.asp
Zeist