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Doctors Orders & Timing of Arrival of Ordersn Saturdays BN available CRC 2013 Calendar Study Staff Update
Access to Doctor Orders Panel Tests Discounts ! Responsibilities for Reporting Amendments ! Changes for New Special Fund #

Metabolism and Nutrition meal tickets

 

CRC 2013 Calendar

 

Saturdays BN available     top

AVAILABLE SATURDAYS for Registered Dietitans (RDs) 2010

Bionutrition/Metabolic Phenotyping Core

January 9 and 23

February 6 and 20

March 6 and 20

April 3 and 17

May 1 and 15

June 5 and 26

July 10 and 24

August 7 and 21

September 11 and 25

October 2 and 23

November 6 and 20

December 4 and 18

Subject to change based on visit requests.

For questions, contact Ellen J. Anderson, MS, RD, LDN

617 724 2830 eanderson1@partners.org

 

CRC Dress Code Policy top

Dear Study Staff:

The warm weather is here, and with that brings all the fun of summer, including the Red Sox, the Celtics (can you believe it!) and our warm weather attire.

I am writing you to gently remind you about the hospital dress code policies. As we get into the nicer weather everyone starts to wear their summer attire, and some of it is not always appropriate/professional for a clinical unit.

For example: Open toe shoes cannot be worn in the clinical areas or the lab area. If you come up to White 13 or CNY with open toe shoes on please bring a pair of closed toe shoes to change into if you are going to be interacting with subjects in the exam rooms or going into the lab.

Feel free to call or email me if you have any questions.

I have attached the Lab policy and the Nursing policy for your review.

Thank you for helping us to maintain a professional, safe environment for all of us.

Kathy
Kathryn E. Hall, MS, RNCS, ANP-BC
Nursing Director
Clinical Research Center
White 1309
Massachusetts General Hospital
Boston, MA 02114
617 726-3295 (phone)
617 726-7563 (fax)
khall7@partners.org


New and Improved MD Order top

Dear Study Coordinators,

We have good news!

We have a subgroup that has been working very hard in an attempt to streamline the MD orders. This is an effort to make everyone's life much easier. Attached below are the new MD order templates. As you will see, we have separated the orders into 3 parts. The face sheet, the actual orders and the last section is the processing.

Faith has also incorporated lines/sections to make it easier for you to input your orders without the data getting lost on the page and blank pages being printed up. This work was actually done after suggestions from some of the Study Coordinators.

(Please note, if you do by accident "double click" within the document and the document header/footer gets jumbled up, just hit the undo button before you hit save).

We are going to be using these orders for all new protocols. In an effort to be uniform in all of our work, and to clean up the orders that are "less than ideally organized" we are going to be redoing all existing orders.

The protocol nurses will be reaching out to you over the next few weeks to work out how best to coordinate these efforts for each of your individual SPIDS.

While there may be some upfront work getting this done, in the long run this will help everyone operate more efficiently. Please feel free to contact me with any questions.

PS: Please remember that you are the holder/owner of the word version of the MD orders. It is essential that you maintain these and keep them on file for further revisions and edits. Recently we have had a few Study Coordinators that have not kept them and have had to redo their orders from scratch which is a very painful process. Faith is unable to convert PDF files back to word files.

Thank you. Kathy

Kathryn Hall, MS, RNCS, ANP-BC
CRC Nursing Director

Doctors Orders & Timing of Arrival of Orders      top

As a reminder,

When sending CRC Doctors Orders to my attention after discussing them with the CRC Protocol Nurse and/or CRC Protocol Bionutritionist or Administrator, please forward to me ALL the orders for that one protocol at the same time. Even though only one of the orders may have been changed/edited, it is essential to post them when I have the whole completed set. This also helps to maintain version control.

Also, when you email the orders to me, please describe the changes being made in a brief paragraph for each visit, in order to speed up the review process. Please specify whether the changes were made due to an amendment number change. If no amendment number coincides with the orders, then please state no new amendment number. If these orders need to be approved for a visit within a few days, please let me know so that I can work with all areas to expedite the approval of these orders.

Please Note: No doctors orders will be posted without a blurb/paragraph of the changes being made.

The doctors orders need to be submitted to the White 13 Front Desk no later than the morning of 2 business days (48 hours) prior to the subject's visit. This will help to facilitate the subject visit.

For example:

VISIT DAY/TIME ORDERS ON UNIT NO LATER THAN:

Weds PM noon Monday
Sunday AM noon Thursday
Tuesday AM (after a holiday) noon Thursday

Thanks for your help!
Faith


 

 

Access to CRC Lab      top

Please note this applies to Study Staff/Coordinators who need access to the White 13/ CRC Lab only.

As many of you know we have installed an ID scanner on the CRC lab this week. To gain access to the lab we need you to read and complete this form.

You can complete this form electronically and email it back to Gerry Cronin or print it up and drop it off to Lue Davis at the CRC.

Please contact us if you have any questions.

Thank you,
Kathy Hall


Standard Operating Procedures(SOPs)          top

CRC Advisory Committee meeting has approved the following SOPs:

1. Adverse Event Reporting

2. Research Subject Advocate Adverse Event Review

3. Review and Approval of Protocol Submissions

4. Data and Safety Monitoring Plan

5. Financial Expenditures and Data Reporting of the CRC Grant

6. Study Closure of CRC Protocols

7. Creation, Review and Revision of Standard Operating Procedures (SOPs)


Access to CRC Posted Doctors Orders         top

As a reminder.... if any CRC Investigator or Study Staff member who would like to have read-only access to their active CRC doctors orders which are posted on the CRC, will need to email me their: (First, Middle and Last Name) in this order, Network ID or logon name (example: FMF0) and Date of Birth. You will then be able to access your CRC doctors orders by rebooting your pc and clicking on (My NetWork Places) on your desktop. Here you should then see a folder called: GCRCM_DO

It might be helpful if you are asking for access to the CRC Doctors Orders directory, if you could also please do the following in your Microsoft Word program add your name to the User Information Section by doing the following on your PC:

Open up Microsoft Word
Go to Tools
Go to Options
Go to User Information (place your name and initials in the space provided)

Please remember that the information contained in the CRC doctors order folders should remain confidential.

Any questions please feel free to contact me.


Faith Fortune, Administrative Coordinator
Massachusetts General Hospital - CRC Program
55 Fruit Street - White 1301
Phone: (617) 726-6886
Fax: (617) 724-3299
ffortune@partners.org

Reduced research charges for panel tests and request for the CRC application          top

Please see message below regarding panel tests and the research discount. If you are able to use panel tests rather than individual lab tests, it will save considerable ancillary expenses for the CRC. Panel test FY 04 Research price:

Comprehensive Metabolic Panel (NA, CL, K, CO2, BUN, CRE, GLU, CA, ALB, ALK PHOS, T.BILI, TP, ALT, AST).
Hepatic Function Panel (Albumin, Alkaline Phosphatase, Total and Direct Bilirubin, Total Protein, SGOT and SGPT ).
Basic Metabolic Panel (Sodium, Po, Cl, CO2, BUN, Cr, Glu, Ca.
Lipid Panel (Chol, Tri, Direct HDL, Calc LDL).

Please review doctor's orders on your studies to see if it is possible that changes may reduce ancillary costs. If you think it is possible that a change in tests that are ordered would reduce ancillary costs, please let me know and then work with your protocol nurse to review and possibly change your doctor's orders.

Thanks to Drs. Robert Neer, Joel Finkelstein and Ben Leder for pursuing this issue with Finance and research management.

Please let me know if you have any questions.

CRC Application update: When submitting a new application to the CRC and your study has been approved by the HRC, please include questions and comments from the HRC. This will enable CRC reviewers to see what issues were raised and addressed with the HRC. We are also working with the HRC to coordinate our application with the new HRC online application, which is currently in a pilot phase. Please let me know if you have any questions.

Thanks.

Edwin Andrews

Administrative Director,
Clinical Research Center (CRC)
White 13
Massachusetts General Hospital
Boston, MA 02114
617 726-6885 (phone)
617 724-FAXX
ebandrews@partners.org

Responsibilities for reporting HRC-approved amendments to the CRC  top

Please see attached memo from David Nathan and the CRC Executive Committee regarding the submission of complete HRC-approved amendments to the CRC. This memo should clarify and simplify what needs to be submitted to the CRC for any approved amendment. Please let us know if you have any questions.

MEMO

DATE: March 9, 2005

TO: Principal Investigators and Program Coordinators

FROM: CRC Executive Committee, David M. Nathan, M.D.

RE: Responsibilities for Reporting Protocol Changes

The CRC is actively working with the HRC for complete access to its database. During the period of transition (probably one year), the CRC must request some documentation that has been sent to HRC. Information is being requested for HRC-approved amendments as noted below.

Timely reporting will ensure that research is carried out as approved by the HRC and that we have all the necessary information reflected in the protocol on the CRC. The guidelines below should serve as a reminder to investigators and their study teams as to which specific information we require and the need for timely reporting of such information:

  • Minor changes : Any change in a protocol that affects its conduct on the CRC must be discussed with the protocol nurse and/or protocol research dietitian prior to submission of the amendment. For relatively trivial (minor) changes, for example, the addition of another test tube during a routine blood draw, review of the amendment by the CRC Administrative staff and RSA is probably not indicated.
  • Substantial changes : However, for more substantial changes in the conduct of a protocol (e.g. change in a medication that will be given, the frequency of administration of a study drug, or the addition of a new measurement on the CRC), the CRC must be informed immediately after approval of the amendment by the HRC. Please do not submit amendment material to the CRC prior to HRC approval. The investigator must submit the following for every approved amendment that reflects substantial changes:
    • HRC Amendment Form
    • Supporting documentation (i.e. revised protocol, revised consent forms)
      • The revised protocol must have an updated revision date and most recent amendment number reflected in the revised protocol summary and/or detailed protocol.
    • HRC Approval Letter
    • Revised protocol schema
    • Revised Doctor’s orders
  • Any changes that affect the CRC budgeting of a study must be submitted. Such changes would include any requests for additional ancillary funding or changed number of study visits or study subjects.
  • Changes in staffing (professional practice requirements) of a study that will affect conduct of the study on the CRC (addition of study-specific staff that will be working on the CRC) must be reported so that we can validate that the staff member has received appropriate MGH training and CRC orientation. If there are new investigators added, we may also request biosketch and other support pages with percent effort and dollars.
  • We may also need supporting documentation on other categories of approved amendments, but will inform you if this is the case.

For approved amendments in the above categories, we will also need a Turbo revision file. Please contact Faith Fortune for the most current version of the Turbo revision file for you to edit.

We hope that this relatively restricted list of reporting requirements will not be overwhelming and that investigators will take the responsibility for communicating such protocol changes in a timely fashion to the CRC. Changes to the conduct of studies on the CRC that are substantive, as noted above, will not be initiated on the CRC until the CRC is informed of such changes and has had the opportunity to review and approve them and plan for their implementation.

The information requested above should be transmitted as a complete package to the CRC within a two-week period of HRC approval. If necessary information is not received, implementation of amendment changes will not be possible and scheduling of subjects may be suspended.

Please keep the CRC team (protocol nurse, protocol research dietitian, RSA and Administration) fully updated on these completed amendments. If you have any questions regarding these instructions, please do not hesitate to call David Nathan or Anne Klibanski.

Edwin Andrews
Administrative Director,
Clinical Research Center (CRC)
White 1301
Massachusetts General Hospital
Boston, MA 02114
617 726-6885 (phone)
617 724-FAXX (fax)
ebandrews@partners.org

Doctor's Orders changes for new special fund #  top

Dear Investigator/Study Coordinator:

If your study has a special fund # associated with it that is on the Doctor's Orders, please revise the orders and return to Faith Fortune for posting on the CRC's shared network drive. If the only change is this new special fund #, please note this in your e-mail. Please note that it is extremely helpful if you summarize in your e-mail to Faith what the change(s) are so that the review of newly revised Doctor's Orders is more efficient. If you have already sent in orders with a new special fund #, thank you for doing so. If the only change is related to the special fund #, the CRC nursing staff has agreed that the Doctor's Orders only needs administrative review. If there are other changes, then the review/approval will go through the usual process. Once these orders are approved, Faith will send you the completed, approved orders with the footer reflecting the date of CRC approval.

Inpatient lab requisitions no longer need any fund number. The allocation of charges will occur upon receipt of the invoice from patient accounts to the CRC administrative office.

Please let me know if you have any questions.

Edwin Andrews

Administrative Director,
Clinical Research Center (CRC)
White 1301
Massachusetts General Hospital
Boston, MA 02114
617 726-6885 (phone)
617 724-FAXX (fax)
ebandrews@partners.org

Upcoming Budget   top

TO: CRC Investigators

FROM: David M. Nathan, M.D.

RE: Upcoming Budget

_______________________________________________________________________

As some of you may know, although our Notice of Grant Award had included a substantial increase in funding for our next budget year (December 1, 2004-November 30, 2005), we have been informed by the NIH institute of NCATS, our sponsoring Institute, that we will be provided with a flat level funding for the coming budget year. Since there are increases in salary and fringe benefits for the staff that must be included for this next year, a “flat level” budget actually means a decrease in the number of dollars that we have to spend on clinical research projects on the CRC. It is conceivable that the usual 2 to 3 percent increase (and, possibly more) could be restored to our budget during the year; however, in the meantime, we must be fiscally responsible and create a budget that we can afford.

At the same time as we have been asked to cut back our budget, clinical research activity and requests for support for new studies are booming. We are in active discussions with the hospital administration as to how we can best accommodate this increase in clinical research.

In order to “balance” our books, we have had to make several budgetary changes. These include: decrease in salary support for leadership on the CRC, decrease or elimination of travel funds for CRC staff to go to the annual meeting, canceling much of the replacement or new equipment that was needed on the CRC, reduction in budget at our MIT satellite, and a number of other small changes in budget. Even with these reductions, we were unable to make up for the shortfall that we would have faced. Therefore, we will need to eliminate the ancillary support that usually goes with inpatient bed days and outpatient visits for all new submissions effective December 1, 2004. The elimination of these funds (usually one-hundred dollars per patient bed day for inpatient admissions and seventy-five dollars per outpatient visit) may not be sufficient to provide a balanced budget and we may need to decrease funding for ongoing studies in the future. In making the decision to eliminate this support for new studies, we wanted to be conscientious regarding the commitments we had already made to clinical investigators and create as little disturbance for ongoing studies as possible. We also had to take into account that the ancillary study budget is the only large pool of resources from which we can make up any budget deficits. The CRC Advisory Committee approved this plan.

As noted above, we hope that the need to restrict ancillary funding for new studies will only be temporary, and that during the year we will be able to restore such funds. The recent passage of the Omnibus spending bill by Congress included a modest increase for the NIH. With any luck, this may trickle down to NCRR and allow us to restore the ancillary budget.

If we are able to restore such funding for the ancillary budget, we will establish a priority list of projects that takes into account whether the applicant has other sources of potential support for their study (more junior investigators, fellows, and K-23 recipients will be given priority). I urge you all to include as much of the “ancillary” costs that are usually reserved for CRC funding on your grant applications. By doing so, you spare what appears to be a dwindling amount of support for the CRC. The kinds of research chores that are paid for by the ancillary budget often include laboratory tests that could be assigned to other research budgets.

We will keep you informed as the year goes on as to how we are fairing with regard to budget. Hopefully we will not need to come back to investigators to decrease your currently approved ancillary budgets.

Metabolism and Nutrition meal tickets on the CRC      top

If your study provides CRC meal tickets during a subject visit, please check with CRC Metabolism and Nutrition prior to providing a meal ticket. We need to make sure that that the correct CRC fund # is being used on any meal tickets. When an expired fund # is used, the subject will be told that they must return to their investigator's office to get the proper fund #. This is an inconvenience for the research subject that we would like to avoid. If you have any questions, please let me know.

Edwin Andrews
Administrative Director,
Clinical Research Center (CRC)
White 13
Massachusetts General Hospital
Boston, MA 02114
617 726-6885 (phone)
617 724-FAXX
ebandrews@partners.org

Standard naming convention for CRC Doctor's Orders     top

As part of the CRC's effort to improve our document management, we have consolidated standard Doctor's Orders for all CRC protocols onto a shared network drive that is accessible to all CRC staff. As part of this effort, we are asking that you name all Doctor's Orders when they are forwarded electronically to Faith Fortune:

SPID123 Screening
SPID123 Visit 1
SPID123 Termination
etc.

Please don't include an extension (.doc) or revision date in the document name. These can be determined in other ways, if needed. The end of the document name (i.e. Visit 1 etc.) should match the name that is on the Doctor's Orders (medication).

Using a standard naming convention will eliminate any possible confusion between study staff and CRC staff when updating Doctor's Orders. Thank you for your assistance.

If you have any questions, please let me know.

Edwin Andrews

Administrative Director,
Clinical Research Center (CRC)
White 13
Massachusetts General Hospital
Boston, MA 02114
617 726-6885 (phone)
617 724-FAXX
ebandrews@partners.org

 

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