Conducting a Study with Us FAQs:
What is a SPID #?
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
What is a Protocol Nurse and Nutritionist and when will they be assigned to the study?
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.
Where do I find my data?
Most data collected at each patient visit will be in EPIC. Some Nutrition information that is not currently uploaded to EPIC (this includes: DXA, Met Cart, questionnaire, BIA, and special menu data) can be found in the Nutrition RFA. Contact Tara Holmes or Faith Fortune for access and instructions to map the drive. The RFA will need to be mapped on each computer used. Source documents, like Food Records and Recalls, will be stored in the Nutrition Office on White 13. Please contact your Protocol Dietitian for details.
Who should I contact to build the TCRC clinical portion of my budget?
Please contact Kathy Hall and Sarah Luthern for nursing and lab processing and Jane Hubbard for nutrition.
Who should I contact if I have questions about my TCRC invoice?
Please email the TCRC Billing mailbox: email@example.com
The Principal Investigator is leaving MGH, what needs to be done?
Per IRB regarding Absentee Investigators: When you are leaving the institution, you need to close out all clinical studies, or formally pass them on to a new Principal Investigator before you depart. Contact Research Compliance/Research Management to obtain and complete a “departing PI” package. If a PI will be away on sabbatical or leave, and not immediately available (e.g maternity or paternity leave, medical or other leave of absence), a covering PI or site-responsible co-investigator fulfilling the role temporarily, should be formally named, by amendment. Ensure your supervisor/division chair agrees. Consider whether contact information in your consent form is still accurate – if the leave is short and there is a secondary contact who can refer participants to the interim PI, one need not necessarily change the PI in the consent form contacts. If a new PI is named, and the study is still enrolling, a consent form amendment is needed.
How do I find TCRC equipment information (Vendor, Serial number, etc)?
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.
Do my doctor’s orders need to be signed? By whom?
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 paper MD Orders and place orders in EPIC if needed. NOTE: TCRC NPs are not able to order investigational meds in EPIC.
Where should I bring my signed doctor’s orders?
Once a visit is scheduled, please drop off the most current signed, dated and timed approved doctor’s orders to the TCRC front desk. Doctor’s Orders should be placed in the “orders folder” at the front desk. Please use the orders log book to sign in the date the orders were dropped off along with your name.
When is the deadline for dropping off orders?
Signed Doctor’s Orders must be received NO LATER than the morning of two business days before the visit. Two days allows sufficient time for study visit preparation. If you are unable to drop off orders by the deadline, please contact the TCRC front desk as soon as possible.
What happens if orders I dropped off are rejected?
The Operations Associate at the TCRC front desk will notify you immediately and will tell you what to do in order for the Doctor’s Orders to be accepted.
Why were my study’s doctor’s orders rejected?
- When there is no watermark
- When the Doctor’s Orders are unsigned
- When the pre-printed Doctor's Orders have been altered. Changes must be made on a separate Doctor’s Order sheet
What if the Doctor’s Orders need to be altered?
Altered Doctor’s Orders will not be accepted. Changes must be made on a separate Doctor’s Order Addendum Orders Sheet and brought to White 12 with the original set of orders. Also, please contact the Scheduler, Protocol RD, and Resource RN directly when making any one-time changes so they can confirm that the necessary resources will be available.
What is the TCRC Tracking Sheet and do I have to use one?
There have been an increasing number of study participants leaving the TCRC prior to completion of all research activities. This has resulted in deviations from protocols, missed data collection, need for rescheduling patient visits, and inconvenience to study participants due to repeat study visits. The TCRC asks that all studies include a tracking sheet with each set of orders for each visit. This will help us better monitor the progress of each visit and contact someone from your team should the need arise. Please refer to the following document on where to find the Tracking Sheet. Protocol_Flow_2020_03_25.pdf
Why might a consent form be rejected at a visit?
All TCRC charts must have a copy of a valid and signed consent form prior to starting a study on the TCRC. Study teams should provide a copy and ensure the consent form was filled out correctly. Before providing a copy to the TCRC ensure the following are correct:
- Patient signature and date/time in correct location
Doctor or study staff consenting signature and date/time in correct location
- If study staff and patient sign on different days, a Note To File should be available to explain the discrepancy
- Signatures date and time within approval and expiration dates
- Complete IRB approval stamp is visible
The subject’s name and medical record number 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. It is also required if a copy of the informed consent will be entered in the electronic medical record. Please also note that SUBJECTS must enter the date themselves on consent forms.
Can the TCRC staff consent patients?
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.
Do consent forms need to be single or double-sided?
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.
How are charts filed in the Medical Record Room?
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).
What are the guidelines for a chart purge?
Charts are not stored indefinitely in the medical records room. Annually a chart purge will be conducted where eligible charts are either sent to Medical Records or a third-party storage center (different for each study, please ask Julia Carney if you are unsure where the chart will be sent if it is eligible to be purged.) A chart can be purged when the patient has completed the study and their last study visit was at least three-months ago or if the study has closed. Best practice is to copy study flow sheets/documents from the patients’ chart when the visit is over so that you are not scrambling when the chart purge occurs. Study teams will always be notified when a chart purge is being conducted.
What needs to be ordered in EPIC? By whom?
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
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.
Where do I find Tip Sheets in EPIC?
In EPIC - Click the dropdown arrow next to PHS Research Home > PHS Research MGH Study Staff > Research Learning Home
You can also find them here
Who reads EKGs and is there a fee?
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.
What if our research subject receives a bill for a study visit?
Please fax [617-724-3299] or deliver the bill or invoice to TCRC administration on 125 Nashua Street, Suite 823 and we will investigate. If it is appropriate for the TCRC to pay for services on this invoice, we will provide the fund number to the billing agency. If it is not a service covered by our grant, we will notify you.
Will the TCRC pay for professional fees?
TCRC regulations prohibit our funds from being used for payment of professional fees.
What visit information do you need to provide?
You may be asked to provide visit information on an ancillary only visit or another offsite visit. If your study has offsite visits, please contact Faith Fortune for the form to be completed monthly for your study.
How can I reference the CRC in my publications?
SUBMIT YOUR PUBLICATION(S) TO THE CLINICAL RESEARCH CENTER:
Publications resulting from the use of CRC resources is one metric evaluated by Harvard Catalyst and the CTSA grant. Therefore the CRC requests your timely submission of your publication(s).
Please complete the following Journal Article Template.docx. Once complete, please forward to Faith Fortune at firstname.lastname@example.org. Please make sure you note the CRC SPID number(s) associated with each publication as well as use all the appropriate Grant Numbers if applicable. Also, reference your PMID and PMCID numbers on all publications / journals that you submit to the Clinical Research Center (CRC).
Citing Your Harvard Catalyst in Your Publications and Posters:
Each publication, press release or other document that cites results from NIH grant-supported research must include an acknowledgement of NIH grant support and a disclaimer.
For studies that included activity 05/01/18 or later, please use grant number the acknowledgement must include "The project described was supported by Grant Number 1UL1TR002541-01"
- For studies that included activity after 10/01/13 or later, the acknowledgement must include "The project described was supported by Grant Number 1UL1TR001102"
- For studies that included activity 05/01/12 to 09/30/13, the acknowledgement must include "The project described was supported by Grant Number 8 UL1 TR000170, Harvard Clinical and Translational Science Center, from the National Center for Advancing Translational Science"
- For studies that included activity between 06/01/08 to 04/30/12, the acknowledgement must include "The project described was supported by Grant Number 1 UL1 RR025758, Harvard Clinical and Translational Science Center, from the National Center for Research Resources"
- For studies that included activity prior to 06/01/08, the acknowledgement must include "The project described was supported by Grant Number M01-RR-01066, from the National Center for Research Resources"
"The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources, the National Center for Advancing Translational Science or the National Institutes of Health".
CRC Publications to Date using CRC Resources:
How long is the study approval process?
Studies are generally approved on the TCRC within 30 days of submission. Approval of a study could be affected by a delay in HRC approval and/or delays in responses from the TCRC reviewers and/or investigator.
What is the process for approval of a protocol?
See Information for Investigators on our website.
In summary, the TCRC protocol team, including scientific reviewers, reviews the protocol and provides comments on a critique sheet. The critique sheet is edited and forwarded to the Principal Investigator for a response. Approval is contingent on a satisfactory response to the critique, finalizing study orders and completing scheduling templates.
Once this process is complete, a TCRC Approval Letter is sent to the PI from Faith Fortune. Scheduling may then commence.