A SPID number is the "Subproject Identification Number" for a TCRC study, which is assigned when the study is submitted to the TCRC for review. Example: SPID 0001

A Protocol Nurse and Nutritionist assist with the development of a study’s doctor’s order. They are assigned to the study once the study has been submitted for review.

Most data collected at each participant visit will be in EPIC. Paper documents generated during visit (i.e. skin prick tests, procedural consents) will be available for pick up at the TCRC Front Desk. Select Nutrition information is not uploaded to EPIC (i.e. DXA, Met Cart, questionnaires, BIA, and special menu data). Contact Tara Holmes for access to the TCRC OneDrive data storage folders. Source documents generated, like Food Records and Recalls, will be stored in the Nutrition Office on White 1308. Please contact your Protocol Dietitian for details.

Submitting a Budget Request to the TCRC.pdf. Please contact Kathy Hall and Sarah Luthern for nursing and lab processing and Jane Hubbard for nutrition.

Please email the TCRC Billing mailbox

Information regarding the PI Transfer Out process can be found here: https://researchintranet.mgh.harvard.edu/transfer-out-2/ 

For Nutrition equipment information (ex. Metabolic Cart, DXA, BIA, etc), please contact Jane Hubbard. If you are part of an active study, log into your study page and review the Documents tab.

For Nursing, MGH Biomed will have the information.

For the Lab, please contact Amanda Griffin.

https://partnershealthcare.sharepoint.com/sites/Vitals/SitePages/Research-and-Education.aspx

Yes, all orders must be signed by a study MD, NP or PA. It is against federal law to use orders that have not been signed by an MD, NP or PA or that have been altered by somebody other than an MD, NP or PA on the study team.

TCRC NPs and FNPs are available to sign MD Orders and place orders in EPIC if needed, but must be added to the study in Insight. 

NOTE: TCRC NPs are not able to order investigational meds in EPIC.

Signed MD Orders must be completed electronically in TCRC Website NO LATER than the morning of two business days before the visit. Two days allows sufficient time for study visit preparation. 

Electronic MD Orders can be edited by the team prior to the day of the visit by removing MD signatures, making edits, and re-submitting to MD/NP for signature. 

If Scheduling template requires adjustment to add or remove a TCRC resource, please contact the TCRC Scheduler, Resource RN and Resource RD to ensure billing and resources are accounted for accurately.

All TCRC participants must have a copy of a valid and signed consent form prior to starting a study on the TCRC. Study teams should upload all consents to EPIC in the Media tab. If ICF is acquired on paper on the TCRC, the consent can be shown to TCRC first then should be uploaded to EPIC immediately. 

Before providing a copy to the TCRC ensure the following are correct:

• IRB approval footer or stamp is visible
• Participant signature and date/time in correct location
• Doctor or study staff consenting signature and date/time in correct location - Study staff must sign after participant
  • Signatures date and time within approval and expiration dates
  • If study staff and patient sign on different days for a paper consent, a Note To File should be available to explain the discrepancy
• Two-participant identifiers must be available. 
  • The subject’s name, MGH 7-digit medical record number, and/or date of birth should be recorded on each page of the informed consent documents. 
  • This is necessary for FDA inspectors, auditors, and monitors to verify who signed the consent. This is specifically authorized by the signing subject as part of the HIPAA “boilerplate” and not a “HIPAA violation” as mistakenly noted by some staff during audits.  

TCRC NPs and FNPs can be added to study IRB contact pages if a study requires assistance with consenting and CRF’s. Please contact Kathy Hall with further questions on MD/NP privileges and TCRC NP utilization on your study.

There is no policy preventing consent forms from being printed double-sided, both the IRB and QI recommend single-sided to avoid pages being lost.  When you’re copying consents, please ensure that all pages are present.

Patient charts are filed in a systematic way in the Medical Records Room. First choose the correct filing drawer based on the last two digits in the patients MRN. Then find the section of charts that have the same last two digits as the chart being filed. The charts should be filed in a chronological order based off middle two digits of MRN. If the chart being filed has the same middle and last two digits as a currently existing chart use the first three numbers to file chart in a chronological order with existing charts. If you forget the process, please refer to the instructions posted in the medical records room. If you have any questions/concerns, please ask someone for help! Misfiled charts can lead to duplicate charts or lost charts which can be a breach of confidentiality! (Instructions attached in email).

Hard copies of patient medical records are not stored indefinitely in the medical records room on White 13. The hard copies of patient medical records are scanned to Medical Records for permanent electronic storage in EPIC, under the media tab.

Prior to the beginning of a visit. Associate the patient to Research. Doing this will give the patient that “pink tag” in EPIC near their demographics. Link the HOV (encounter) to research (HOV is created by TCRC). All the following must be ordered as well:

1. All labs that will be done at the MGH Core Pathology Lab
2. All EKGs
3. All Imaging studies
4. All Medications – research/investigational medications, rescue medications, supplements and flushes
5. Allergies/Medications/Code Status must be reviewed by the PI

Further information and Tip Sheets are available for EPIC ordering.

Every study must have an MD or NP with MGH privileges available. This is required to place orders in EPIC. TCRC NPs and FNPs are available to place orders in EPIC if needed. NOTE: TCRC NPs are not able to order investigational meds in EPIC.

Inpatient studies only: Admitting privileges

Confirm someone on team has admitting privileges. To confirm use this link: http://mghmso.massgeneral.org/PrivInq/msopi.aspx (located in Partners menu > Clinical References > MGH- Delineation of Privileges Intranet Site)

Contact Registrar Office if privileges are needed.

Epic tip sheets can be found here

If a study involves an EKG on the TCRC, the EKG should be reviewed and documented on by the study PI or a TCRC NP during the visit and before any medications are given.  If the TCRC NPs are not on the study they can still review the EKG and put a note in EPIC.  If the PI is not able to review the EKG and write a note then the TCRC NP will be placed on the template for 15 minutes to review and document on the EKG.  Questions about charges should be referred to Kathy Hall, Nurse Director.

Please scan a copy of the bill or invoice to TCRC administration and we will investigate.

TCRC regulations prohibit our funds from being used for payment of professional fees.