The protocol Regulatory Person goes to the website

Check on the team she is in

Pulmonary

Hepatology

Oncology

Neurology

Endocrinology

Infectious Disease

Gynecology/Reproductive Medicine

Cardiology

Also at this level we need to house our templates. We could make it an assigned team name – but they need to be easy to get to so all PRA’s – Doctors – everyone – uses our assigned templates where applicable. This team, Templates – would need the Announcements feature and Messages to one another.

I would only have this as one level, if we break down the Oncology for example, then we would be getting the protocol information too buried in the document library.

So, the regulatory person goes to the team folder

Announcements

Messages

Or find her protocol listed by number – or she makes a new protocol which she is going to submit to the CTRC or CTO.

  1. She needs a folder called Protocol Documents – we could break it down farther – the people going into this folder would be the protocol manager, all people keeping track of current documentation, etc. current people would be Pat Kittelson, Ade Benson, Elle Lothlorien’s replacement, Susan Switz, Vicky Allen – administrative people tracking all expiration dates, etc.
  1. Protocol and Investigators Brochure and the CV all could be in one folder, Attachment W
  2. The approvals can be in one folder called Approvals and in this folder one could put the HRRC approval, the HIPAA approval document, the IRB approval document.
  3. There should be a folder with the current, stamped consent and the current HIPAA form
  4. Budgeting issues
  1. Another folder needed would be Correspondence. We could put the CTRC or CTO approval letter in here as well. It would make sense if all correspondence goes into the same location. Everyone would need permissions to put documents into this folder
  1. Doctors orders. People who need permissions for this folder are PRAs, all the nursing staff, and the PI. There will be many changes to these documents as the protocol progresses. We need to house a link going to the template our nursing staff requires all protocols to use for their doctors orders, and when the PRA saves her filled out doctors orders, they need to be saved in this folder – leaving the master template blank for the next person.
  1. Nursing folder. This would only be people who work with the flowsheets, making all changes, etc. The PRA could have read only access – but all the nursing staff needs to be able to work on the paperwork needed during the actual appointment with the patient.
  2. Billing. – This needs to be looked at by the PRA and they need to be able to approve whatever is put there by administrative people. All people involved in the billing process need permission to add documents, delete them, approve them – everything. The PRA can approve them, make notes on them, but cannot delete anything. Mary Schumer’s office and staff need to look in this folder also.
  3. Patient Information – we keep the signed consent and the signed H&P. We don’t keep anything else and we keep them all.

The first person to use the protocol library will be the regulatory person. I imagine she could use the folder while she is gathering her protocol paperwork – and when she is finished, she could contact the CTRC or CTO submission person and announce all is ready. Then our staff person goes to the folder and begins to work with the documents. The regulatory person could also announce to Mary Schumer’s office that the paperwork is in our sharepoint location, so we could give Mary Schumer and her staff whatever permissions they would need.

She will look in all the protocol folders. I think Mary Schumer’s office will look in all the protocol folders.

All correspondence between these people can be housed in the correspondence folder.