03Sep2024
Portal Team meeting: new name! "OpenRegSource"
Front page updated.
Decided to add Search box to all pages.
Tweaked TOC.
Did a bunch of updates to the main pages.
Aug 6 2024
Made email list signup form and embedded it on a new page.
Added link to it on front page.
Aug 1 2024
All fixes done.
Contact and survey pages updated.
Posted new page tree here.
Made new links Excel sheet for site map.
Added link on front page to new modules page.
Made site map. Added link to it in table of contents.
Add links to "Drugs & Biologics" and "Devices" pages.
Jun 12 2024
Focus group completed.
Awaiting final compilation of results.
Changes/fixes to come.
The Portal URLs have changed - all URLs now have "-draft" in them.
All previous links and bookmarks will not work.
New and permanent URLs will be made for launch.
Portal will live under Research Resources navigation.
Mar 13 2024
Finally got paid Google search to work!
Now can search the site without ads.
Mar 6 2024
Made collage of photos and added to front page.
Made contact form and added link. Karen M. gets notification.
Also added Karen to get notifications from Feedback form.
Feb 6 2024
Added "Return to Front Page" button to ALL pages (except front page)
Changed title of Therapeutics pages to "Drugs & Biologics".
Revised Table of Contents to say "Drugs & Biologics"
Made side bar, and moved Feedback, Consultation, Contact and Credits into it.
Made new Drugs and Devices parent pages, so that the URL will say one of the other. No content on these pages, and no links actually go to these pages, but I did put a Go to Front Page button and a Table of Contents on each, in case someone finds them by accident. At least they can go somewhere.
Revised URLs, and took off "therapeutics" and "devices", since they will be under the parent page as described above.
Fixed several glitches in Glossary entries. Added "Go to top" buttons.
Added missing image to Clinical Research - Devices page.
Changed format of photos on Devices types pages.
It was decided to pay for an ad-free custom Google Search.
Jan 16 2024
Built-in Choices for Portal Home button format:
Return to Regulatory Portal front page
Return to Regulatory Portal front page
Return to Regulatory Portal front page
Added content to Device type pages:
https://sc-ctsi.org/about/regulatory-resources/devices-front-page/class-i-devices
https://sc-ctsi.org/about/regulatory-resources/devices-front-page/class-ii-devices
https://sc-ctsi.org/about/regulatory-resources/devices-front-page/class-iii-devices
https://sc-ctsi.org/about/regulatory-resources/devices-front-page/combination-products
https://sc-ctsi.org/about/regulatory-resources/devices-front-page/in-vitro-diagnostic-ivd-products
Jan 8 2024
New pages:
Manufacturing - Devices
https://sc-ctsi.org/about/regulatory-resources/devices-front-page/manufacturing-devices
Clinical Research - Devices
https://sc-ctsi.org/about/regulatory-resources/devices-front-page/clinical-research-devices
Jan 3 2024
New page added: Regulatory Paths to Market - Devices
https://sc-ctsi.org/about/regulatory-resources/devices-front-page/regulatory-paths-to-market-devices
Dec 13 2023
Updated What Is My Medical Product? page with new images and links:
https://sc-ctsi.org/about/regulatory-resources/what-is-my-medical-product
I need to add padding to the Devices section of the table. - DONE
Added new images to the individual pages as well.
Custom Google search (placed on the front page):
https://cse.google.com/cse?cx=904afbf34515a4e1e#gsc.tab=0
All pages now have Resources as accordioned content, with a link in the right column directly to it.
New Patenting page for Devices up.
Added a Credits page - needs content.
https://sc-ctsi.org/about/regulatory-resources/credits-and-acknowledgements
Need to add copyright to all pages? - Added to front page.
Nov 28 2023
Made a custom Google search engine for the site. It works, but it's a public search, so paid ads appear on top first.
We could apply for an educational institution free custom search engine.
Added link to the right column on front page. Maybe it goes here on every page? - no
Nov 22 2023
Added content to Therapeutics Clinical Research, Regulatory Paths, and Patenting pages.
Added new flow charts to Manufacturing page.
Changed all Resources content to accordion-style.
Added sidebar link to Resources on all these pages.
Removed Paths and Clinical Research sub-pages. Structure is much tighter now.
New tree structure graphic added to this page.
Nov 1 2023
Added content to Therapeutics Manufacturing page. Flow chart graphics should be re-done. Not clear.
Changed the term "Commercialization" to "Regulatory Pathway to Market". Had to change that on all side bars.
Sep 14 2023
Added new text and navigation to portal front page.
Let's add a custom search bar on the front page that gives results only from the regulatory portal, not the entire site. Could be a Google search (would have Google branding on it), or built by Clearfire, the website contractor we use.
Do we need an FAQ? What about a tutorial on how to use the site?
Sep 12 2023
New images of page tree structure.
Links to sections:
Front page
What is my medical product?
Therapeutics
Devices
Consulting
Feedback form
Glossary
Fall 2023
Lots of new pages, made from Drugs and Devices documents.
April 25 2023
Made a new site tree structure with new pages, using Annie's document as a blueprint. I have moved old pages into another branch.
Added updated structure graphic to this page.
April 1 2023
Added return links to new pages.
Checked all pages for errors from migrating to new platform.
Mar 7 2023 - Add links to FDA & clinicaltrials.gov glossaries to Glossary page. Also add "Go to top" links.
Add email field to Feedback form
Made Resources page - grab resources from Modules?
Links to add:
https://www.nccih.nih.gov/research/resources - which page?
https://www.fda.gov/drugs/investigational-new-drug-ind-application/investigator-initiated-investigational-new-drug-ind-applications - added to Drugs page
https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/cder-small-business-and-industry-assistance-sbia-learn - which page?
Make it user friendly & narrative.
Can use elements & structure from Eunjoo & Susan's textbook for content.
New pages:
Feedback: https://sc-ctsi.org/about/regulatory-info-consulting-portal/feedback
Glossary: https://sc-ctsi.org/about/regulatory-info-consulting-portal/glossary
Resources: https://sc-ctsi.org/about/regulatory-info-consulting-portal/resources
Mar 3 2023 - Re-named Feedback page to "Tell what you think!". Renamed Glossary page "Glossary of Terms used in Regulatory Science". Deleted Survey page.
Created survey form in Formstack. Embedded form onto Survey page.
Copy/pasted Terms from Monitoring and Auditing modules onto Glossary page. Made contents link to each alphabetic section for easy navigation.
Formstack can also do dropdown menus. Would that be useful for this portal?
Feb 13 2023 - Glossary, Feedback/Survey pages created. No content yet. May be able to copy glossaries from past symposia. Links added to portal front page as well.
Feb 6 2023 - new sections created: Biologics, Dietary Supplements, Cosmetics. Here are links to the pages, but no content in them yet.
https://sc-ctsi.org/about/regulatory-info-consulting-portal/biologics
https://sc-ctsi.org/about/regulatory-info-consulting-portal/dietary-supplements
https://sc-ctsi.org/about/regulatory-info-consulting-portal/cosmetics
Also put links to these sections on Portal front page. They need graphics and formatting still. Ideas for what the photos or graphics could be welcomed!
Nov 18 2022 - Added photos to each page. Tightened up some of the formatting.
- Intro text on front page needed. Updated links needed on several pages. Missing articles.
- Should there be Previous and Next buttons to take you through the whole structure? DONE. Next page and back to front page links added
- We need a page for other regulatory programs or services. I think a student researcher is working on this?
- Should we put a button at the bottom of each page to ask for consultation service? Something like "Need more info? Ask for a consultation"? Or is just the consultation services page enough? Consult page is enough.
Most of what is currently on these pages is copy-and-pasted from our old consultation site, with some updated links. Any link not present was one that didn’t work and we couldn’t find an updated version. Please double-check that all the links on each page work. I'm sure some of the info is out-of-date.
(Scroll down to the bottom of this page to see the structure of the portal pages.)
All comments welcome, including any graphics or images suggestions or other formatting ideas.
Front page: https://sc-ctsi.org/about/regulatory-info-consulting-portal
Devices: https://sc-ctsi.org/about/regulatory-info-consulting-portal/devices
Drugs: https://sc-ctsi.org/about/regulatory-info-consulting-portal/drug-development
IVDs: https://sc-ctsi.org/about/regulatory-info-consulting-portal/ivds
R
egulatory Consultation Services: https://sc-ctsi.org/about/regulatory-info-consulting-portal/regulatory-consultation-services
Devices sub pages
https://sc-ctsi.org/about/regulatory-info-consulting-portal/devices/basic-research-devices
https://sc-ctsi.org/about/regulatory-info-consulting-portal/devices/clinical-trials-for-medical-devices
https://sc-ctsi.org/about/regulatory-info-consulting-portal/devices/fda-filing-approval-devices
https://sc-ctsi.org/about/regulatory-info-consulting-portal/devices/preclinical-development-of-devices
https://sc-ctsi.org/about/regulatory-info-consulting-portal/devices/quality-system-regulation-devices
Drugs sub pages:
https://sc-ctsi.org/about/regulatory-info-consulting-portal/drug-development/basic-research-drugs
https://sc-ctsi.org/about/regulatory-info-consulting-portal/drug-development/drug-development-clinical-trials
https://sc-ctsi.org/about/regulatory-info-consulting-portal/drug-development/fda-filing-approval
https://sc-ctsi.org/about/regulatory-info-consulting-portal/drug-development/gxps
https://sc-ctsi.org/about/regulatory-info-consulting-portal/drug-development/gxps/glp
https://sc-ctsi.org/about/regulatory-info-consulting-portal/drug-development/gxps/gmp
https://sc-ctsi.org/about/regulatory-info-consulting-portal/drug-development/gxps/gcp
https://sc-ctsi.org/about/regulatory-info-consulting-portal/drug-development/drug-development-preclinical-trials
Front page:
https://sc-ctsi.org/about/regulatory-resources
Current page structure as of August 1 2024:
NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.