Investigator Manual
IX.
Requirements for Inpatient Admissions to the CRC:
·
Admissions should be scheduled as far in advance as possible, in order to assure that
there is appropriate bed availability. Scheduling is done with the Unit Coordinator, (667-3351).
·
A pre-admission form, obtained from the Unit Coordinator, Claire Migliero at 617-667-
3351, must be completed for each subject and sent to the CRC no later than one (1) week prior to the admission date.
·
The investigator should review the protocol requirements with the subject before
admission.
·
Review of any costs for the subject (what is covered by research funds and what is not)
is encouraged before admission.
·
As with any patient admitted to BIDMC, all
patients admitted to the CRC must be under the care of a licensed, credentialed BIDMC physician and all requirements for BIDMC
patient admissions apply to CRC patients including MD coverage, completion of a medical history, physical examination, orders and
documentation according to standard, clinical BIDMC policies.
- Each investigator is responsible for the care of
subjects/patients admitted under his/her protocol, either personally or through designated co-investigators, fellows, or
residents. Arrangements must be made for night and emergency coverage and for when the investigator is away from the medical
center. Phone numbers where these designated physicians can be reached must be written on the order form.
·
Physician orders, signed by the responsible MD, who is an investigator on the protocol,
must be provided to the CRC on admission.
·
Review of each subject’s special dietary needs with a CRC research nutritionist is
recommended. Please contact the Chief Bionutritionist at 617-667-3586.
·
A copy of the properly signed and
witnessed consent form must be placed in the medical record on admission.
·
The responsible physician must see the patient, perform an admission
history and physical examination and document in the medical record within 24 hours of admission, before any study interventions
are done, to ensure the participant is able to participate safely. (policies MS-18: Patient Admission, Ambulatory Visit, Initial Assessment and Care Planning by the Medical Staff [Word document] and MS-21: Documentation of the Medical History and Physical Examination [Word document]).
Each item must be completed with an assessment or “not
applicable”.
·
This admission note in the medical record must include:
1.
medical history and current medical diagnoses
2.
physical exam with review of all systems
3.
all current medications including any discontinued for the study
4.
if applicable: summary of any other testing done right before CRC admission including any non-CRC study testing and any
adverse events
5.
any other recent problems or events
6.
statement that subject met study entry criteria
·
If subject is taking new or previously unknown meds, a follow up call to the PCP is necessary to
determine if the subject has a medical condition which might exclude him/her from study participation. Note: Not all subjects
inform their PCP of study participation.
- If it discovered that the subject is also participating in another research study at the same time or has just
completed another study, the investigator is required ask the participant’s permission to contact the other PI and determine if
either study would interfere with the other before the study begins.
- If subject was seen in clinic by the MD within 24 hours before admission, the medical history and physical examination
was done at that time and the note is in OMR, repeating this documentation at admission is not necessary. Simply include in the
admission note “see OMR” and address if there are any changes.
- Patients must be seen and evaluated by a physician daily during admission and daily progress notes on the approved
BIDMC progress note form are required. (policy MS-26: Documentation of Progress Notes by the Medical Staff [Word document])
- Unlike the clinical units at BIDMC, to protect research participant’s privacy, the CRC research patient’s admission
does not require a discharge summary or contacting the patient’s care provider with a reconciliation of medication on discharge. It
is recommended however, that a note is added to the medical record stating that the participant was admitted for participation in a
research study on (date) and discharged on (date). If medications were discontinued for the study, include documentation re:
restarting of medications.
Orders
- Physician admission orders are required on admission. (policy MS-20: Requirements for Physician Orders [Word document])
- Preadmission template/standard orders per protocol are acceptable if approved by the CRC nurse study coordinator but
must be reviewed and updated as needed and signed at the time of admission.
- Admission orders must include: CRC study number and visit number, meds, labs, tests, diet, activity, pain management,
etc. as with any admitted patient. An order to discharge the subject after study visit is completed, if stable, may be included in
admission orders if appropriate.
- Each medication must be written out on the medication order sheet and signed by the physician. Please note: the CRC
does not have POE so written medication orders are required.
- Every medication order must have a corresponding medical diagnosis (as is required in POE) written on the order.
The medical records of the CRC are governed by the
standards established by the Joint Commission on the Accreditation of Hospitals Organization (JCAHO) and the BIDMC medical staff
bylaws.
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The
Harvard-Thorndike CRC is funded by Grant M01 RR01032 from the NCRR, NIH
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