Instructions : Complete this intake portal for any new clinical research study that requires SMCH resources. Study teams will need to identify any potential study procedures or activities that require hospital involvement or support, including those occurring in SMCH patient-care spaces, to complete this survey.
Study teams should complete this intake early on in the study activation/development process, ideally prior to, or in parallel with, budget development and IRB submission.
Note: Completing this SCH Research Intake Portal is not a substitute for any RMG protocols or processes. The purpose of the SCH Research Intake Portal is to connect School of Medicine research teams to the proper units and points of contact at SCH in preparation for research, and does not replace necessary collaboration with RMG. Completing the SMCH Research Intake Portal early in the study startup process can inform RMG processes and budget development.
Steps to complete process:
Step 1: Study team member completes this intake portal by indicating the departments, patient care areas, and/or services that may be required. For each SMCH department you select, you will be prompted to answer additional questions about your study that are specific to that department.
STEP 2: Hospital Departments Notified: Once you complete submit the Intake Survey electronically, REDCap will send automatic notifications to each SMCH department with information you entered.
STEP 3: Research Team Notified: Your study team will receive an auto-notification email for each selected SCH department with information including time to respond, who to contact, or, if the department will contact you. Each department varies in their follow-up process and you can always reach out to us at the CRSO with any questions or concerns.
This intake initiates communication between your research team and the SCH department contacts. The individual designated as the Study Contact will receive emails from the various units and be responsible for any follow-up.
Please add the name and email of the study contact.
First Name Last Name: Email Address: Telephone:
First Name:
* must provide value
Last Name:
* must provide value
Email Address:
* must provide value
Any follow-up will be sent to this email address.
Study Title
* must provide value
E-protocol number, if available
* must provide value
Principal Investigator:
* must provide value
Please list the full name of the main Stanford PD/PI
Principal Investigator's Department:
Anes- Cardiac Anesthesia Anes- Critical Care Medicine Anes- Global Health Anes- Multispecialty Division (MSD) Anes- Obstetric Anesthesia Anes- Pain Medicine Anes- Pediatric Anethesia CardThorSurg- Adult Cardiac Surgery CardThorSurg- Pediatric Cardiac Surgery CardThorSurg- Thoracic Surgery ChEMH- Chemistry, Engineering & Medicine for Human Health CVI- Stanford Cardiovascular Institute Derm- Dermatology, All Specialties EMed- Emergency Medicine (Adult) EMed- Emergency Medicine (Pediatric) HRP- Health Research & Policy Med- BMIR (Biomedical Informatics Research) Med- CV Med Med- Endocrinology Med- Gastroenterology and Hepatology Med- Hematology Med- Hospital Medicine Med- Immunology and Rheumatology Med- Infectious Diseases Med- Nephrology Med- PCCM (Pulmonary Critical Care) Med- PCCM/Sean N. Parker Center Med- Primary Care and Outcomes Research Med- Primary Care and Population Health Med- SCCR (Stanford Center for Clinical Research) Med- SPRC (Stanford Prevention Research Center) MI- Microbiology and Immunology Neuro- Autonomic Disorders Neuro- Child Neurology Neuro- Epilepsy Neuro- Global Health Neurology Neuro- Headache Neuro- Memory Disorders Neuro- Movement Disorders Center Neuro- MS and Neuroimmunology Neuro- Neuro-Oncology Neuro- Neuromonitoring (IONM) Neuro- Neuromuscular Disorders Neuro- Neuropsychology Neuro- Stanford Alzheimer's Disease Rsch Ctr Neuro- Stanford Stroke Center NeuSurg- Brain Tumor Center NeuSurg- Center for Compassion and Altruism NeuSurg- Cerebrovascular Neurosurgery NeuSurg- Epilepsy NeuSurg- Functional Neurosurgery NeuSurg- Head and Spine Trauma NeuSurg- Neurosciences Institute NeuSurg- Pain NeuSurg- Pediatric Neurosurgery NeuSurg- Pituitary Center NeuSurg- Radiosurgery/CyberKnife NeuSurg- SCBPC (Stanford Concussion & Brain Perf. Ctr) NeuSurg- Spine and Peripheral Nerve Surgery Ob/Gyn- Family Planning Ob/Gyn- Gynecologic Oncology Ob/Gyn- Gynecology Service Ob/Gyn- Maternal Fetal Medicine Ob/Gyn- Reproductive Endocrinology & Infertility Ob/Gyn- Reproductive, Stem Cell and Perinatal Biology Ob/Gyn- Urogynecology OHNS- Audiology OHNS- Comprehensive Otolaryngology OHNS- Facial Plastic & Reconstructive Surgery OHNS- Head and Neck Surgery OHNS- Laryngology OHNS- Otology & Neurotology OHNS- Pediatric Otolaryngology OHNS- Rhinology OHNS- Sleep Surgery Ophth- Ophthalmology Ophth- Vision and Ophthalmology Interest Group (VOIG) Ortho- Arthritis & Joint Replacement Ortho- Foot & Ankle Service Ortho- Hand & Upper Limb Service Ortho- Hip Preservation Center Ortho- Musculoskeletal Tumor Service Ortho- Orthopaedic Surgery Ortho- Pediatric Orthopaedic Service Ortho- Physical Medicine & Rehabilitation Ortho- Spine Service Ortho- Sports Medicine Service Ortho- Trauma Service Path- Pathology Peds- Adolescent Medicine Peds- Allergy, Immunology, Rheumatology Peds- Cardiology Peds- Critical Care Medicine Peds- Developmental-Behavioral Pediatrics (DBP) Peds- Endocrinology & Diabetes Peds- Gastroenterology Peds- General Pediatrics Peds- Hematology/Oncology Peds- Human Gene Therapy Peds- Infectious Disease Peds- Medical Genetics Peds- Neonatal and Developmental Medicine Peds- Nephrology Peds- Pediatric Hospital Medicine Peds- Pulmonary and Asthma Peds- Stem Cell Transplantation & Regenerative Medicine Peds- Systems Medicine Psych- Admin and Academic Special Programs Psych- Center for Sleep Sciences and Medicine Psych- Child & Adolescent Psych. & Child Development Psych- Ctr. for Interdisciplinary Brain Sciences Research Psych- General Psychiatry and Psychology Psych- Major Labs & Clinical & Translational Neurosci. Incubator Psych- Public Mental Health and Population Sciences Psych- Vaden Center Rad- Body Imaging Rad- Body MRI Rad- Breast Imaging Rad- Canary Center at Stanford Rad- Cardiovascular Imaging Rad- Integrative Biomedical Imaging Informatics (IBIIS) Rad- Interventional Radiology Rad- Musculoskeletal Imaging Rad- Neuroimaging & Neurointervention Rad- Nuclear Medicine and Molecular Imaging Rad- Pediatric Radiology Rad- Radiological Sciences Laboratory (RSL) Rad- Thoracic Imaging SoM- CHRI/Child Health SoM- CHRI/Heart Center Surg- Abdominal transplantation Surg- Clinical Anatomy Surg- General Surgery Surg- Multi-Organ Transplantation Surg- Pediatric Surgery Surg- Plastic & Reconstructive Surgery Surg- Vascular Surgery Uro- Center for Female and Urology and Neuro Urology Uro- General Uro- International Azoospermia Center Uro- Laparoscopy and Endourology Program Uro- Male Reproductive Medicine and Surgery Program Uro- Pediatric Urology Other
Full name of "other" department
Study Title: e-protocol number (if available):
Please select if this is a Compassionate Use/Expanded Access studySometimes called "compassionate use", expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
Is this study for a single patient or multiple patients?
Single patient
Multiple patients (please specify number of patients in enrollment section)
Please upload the current study protocol (draft is acceptable) here. This will prevent delays in review of this study by hospital departments.
Please upload the Investigator Brochure (draft is acceptable) here. This will prevent delays in review of this study by hospital departments.
Please upload the Lab Manual (draft is acceptable) here. This will prevent delays in review of this study by hospital departments.
Please upload the Pharmacy Manual (draft is acceptable) here. This will prevent delays in review of this study by hospital departments.
How will your study be funded?
* must provide value
PI NIH Internal grant/funding Industry Foundation Other (Federal) Other (Non-Federal) Unfunded or no funding Other (not listed above)
Name Other Funding Source
Full name of "other" funding source, please.
Tell us more about your study (briefly describe the purpose of your study including the type of study and any investigational drug or device interventions )
* must provide value
Describe your patient population(s) (provide age group, diagnoses or underlying conditions, etc.)
* must provide value
Will your study require outpatient clinic visits?
* must provide value
No
Yes
Unsure
Do you anticipate using any research recruitment materials such as flyers or brochures in outpatient clinics?
Yes
No
For studies that will utilize participant recruitment materials such as flyers or brochures - please refer to the attached document and see additional instructions below.
Please use the attached template to format your participant recruitment material. This is the only Stanford Medicine Children's Health approved template to be used in outpatient spaces only. No recruitment materials are to be posted in inpatient spaces and all brochures/flyers are posted at the discretion of clinic management. Once your study information has been formatted with the SMCH template, please submit to the IRB along with study documents. Once IRB approval is received, use the upload file link to attach the document. In the "comments or feedback" section of the intake form please specify the date range for posting of the recruitment material and confirm the location of the outpatient clinic or clinics where you intend to post the materials. You will be contacted by CRSO with next steps in the review/approval process.
Study patients will have outpatient visits as part of their clinical care and not purely for research activities. However, research-only activities may occur during their clinically -indicated visit.
Please list the outpatient location(s) where study patients will be seen.
LPCH - 725 Welch Road Palo Alto, 94304
Children's Services Watson Ct - Palo Alto, 2452 Watson Court, Palo Alto, 94304
Child and Adolescent Mental Health - 401 Quarry Rd, Palo Alto, 94304
Outpatient MRI Center - 732 Welch Rd, Palo Alto, 94304
730 Welch Road Palo Alto, 94304
770 Welch Road Palo Alto, 94304
1195 W Fremont Avenue Sunnyvale, 94087
Other
Please list other location(s) where study patients will be seen.
Orthopedics - Pleasanton - 5000 Pleasanton Ave, Pleasanton, 94566
Audiology - Los Gatos - 145651 S. Bascom Ave, Los Gatos, 95032
Los Gatos Orthopedic Clinic - 555 Knowles Dr, Los Gatos, 95032
Perinatal Diagnostic Center - Fremont - 2147 Mowry Ave, Fremont, 94538
Perinatal Diagnostic Center - Modesto - 1401 Spanos Ct, Modesto, 95355
Perinatal Diagnostic Center -Mountain View - 2495 Hospital Dr, Mountain View, 94040
Perinatal Diagnostic Center - Palo Alto (within LPCH) - 725 Welch Rd, Palo Alto, 94304
Perinatal Diagnostic Center - Redwood City - 2900 Whipple Ave, Redwood City, 94062
Perinatal Diagnostic Center - Salinas - 212 San Jose ST, Salinas, 93901
Perinatal Diagnostic Center - Santa Cruz - 1685 Commercial Way, Santa Cruz, 95065
Brentwood - 2400 Balfour Road Brentwood, 94513
Capitola - 824 Bay Avenue Capitola, 95010
Emeryville - 6121 Hollis Street Emeryville, 94608
Fremont - 2147 Mowry Avenue Fremont, 94538
Fremont - 2299 Mowry Avenue Fremont, 94538
Los Gatos - 14601 S Bascom Avenue Los Gatos, 95032
Menlo Park - 321 Middlefield Road Menlo Park, 94025
Modesto - 1401 Spanos Court Modesto, 95355
Monterey - 1900 Garden Road Monterey, 93940
Mountain View - 2495 Hospital Drive Mountain View, 94040
Novato - 101 Rowland Way Novato, 94945
Watson Court - 2452 Watson Court Palo Alto, 94303
Pleasanton - 5000 Pleasanton Pleasanton,94566
Redwood City - 2900 Whipple Avenue Redwood City, 94062
Salinas - 212 San Jose Street Salinas, 93901
San Francisco - 1100 Van Ness Avenue San Francisco, 94109
Santa Cruz - 1685 Commercial Way Santa Cruz, 95065
Walnut Creek - 106 La Casa Via Walnut Creek, 94598
John Muir Health's Walnut Creek Medical Center - 1601 Ygnacio Valley Road Walnut Creek, 94598
Other
Please list other outpatient locations.
Please describe when study visits will take place (check all that apply).
Please list days and times outside of business hours.
Please check all spaces that patients/study team members may need access to.
Please list other spaces that patients/study team members may need access to.
Will your study require an inpatient overnight stay?
* must provide value
Yes
No
Please choose the statement that best fits your study:
* must provide value
Study patients will be staying overnight as part of their clinical care and not purely for research activities. However, research-only activities may occur during their clinically -indicated admission.
Study patients require research-only overnight stays that would not be occurring as part of the routine care and only if the patient is enrolled on the study.
Currently, overnight research-only beds are only available at Packard at El Camino (PEC).
Lucile Packard Children’s Hospital Stanford partners with El Camino Hospital in Mountain View to provide inpatient care for pediatric patients.
The Packard at El Camino (PEC) unit is a 24-bed satellite unit of Lucille Packard Children’s Hospital Stanford with 6 beds dedicated to the Sean N. Parker Allergy Research Program. The General Pediatric Service at PEC offers comprehensive care for a variety of general pediatric illnesses.
The care provided at PEC is multidisciplinary and draws from the expertise of on-site Pediatric Hospitalists from Lucile Packard Children’s Hospital Stanford (present 24 hours a day), specialized pediatric nursing staff, pharmacists, dieticians, child life specialists, social workers, and case managers, all in a child-friendly, intimate environment.
We strive to provide exceptional patient- and family-centered care by partnering with patients and families on daily bedside family centered rounds, emphasizing communication throughout the hospitalization, and coordinating with primary care physicians to ensure a seamless transition of care.
Will you study require use of Packard at El Camino (PEC) to support overnight research-only study visits?
Yes
No
I am unsure
How often will a study participant require an overnight research study visit?
What is the anticipated total number of overnight visits per participant?
How often will a research participant require overnight study visit(s), (e.g. twice a year, every 3 months for 18 months)? What is the anticipated total number of overnight research study visits for one participant?
Thank you. The study contact at ______ will receive further instructions about requesting PEC services upon submission of this survey.
Provide estimated date that you will begin recruiting/enrolling patients:
* must provide value
Today M-D-Y M-D-Y
What is the estimated maximum number of study participants you plan to enroll at Stanford?
* must provide value
Max number enrolled at Stanford, not study-wide
Approximately how long is the enrollment period? (ie how many months will you be recruiting participants to reach your enrollment goal)?
* must provide value
Months
Years
How long will each participant be actively enrolled in the study? (i.e. after a participant is enrolled on study how long will they be expected to attend follow-up study visits) ?
* must provide value
Months
Years
Enrollment and Study Timeline: Please enter information for Stanford enrollment only. Do not include non-Stanford sites:
Estimated date that you will begin enrolling patients: Estimated enrollment goal:
Approximately how long is the enrollment period for the study? (i.e. how many months will you be recruiting participants to reach your enrollment goal)?
How long will ONE participant be actively enrolled in the study? (i.e. after a participant is enrolled on study how long will they be expected to attend follow-up study visits)?
To the best of your knowledge, will this study require a site qualification visit (SQV) ?
* must provide value
Yes, this study requires a SQV
No, there is no SQV required
I am unsure
If you are unsure, please ask the primary investigator or protocol director for your study. You can also contact the CRSO at crso@stanfordchildrens.org for guidance.
Select all of the SCH departments you may require for your future research project. More information, including options to initiate communication, will become available after selecting a department.
Scroll down for selected department's information.
Hematology/Oncology
Stem Cell
Does your study have a Roadmap?
Yes
No
Unsure
If Roadmap is unavailable, please provide relevant documents here.
Please upload the Roadmap here. This will prevent delays in review of this study by hospital departments.
Please upload the Mobilization/Apheresis manual (draft is acceptable) here. This will prevent delays in review of this study by hospital departments.
Order Set Order Sets are preconfigured sets of orders defaulted with pre-set recommended dosing and frequency, ready to sign. It can include medications, labs, and nursing communication orders. Orders from an orderset can be reviewed together, selected together, and ordered.
Treatment Plan The treatment plan contains all the medications (including chemotherapy), labs, nursing communication orders and required tests that the patient's primary treating team needs to place in Epic for the patient to receive treatment on a given protocol.
Interpreter Services Lucile Packard Children's Hospital Stanford provides efficient, accurate and timely medical interpretation and translation services for all non-English speaking and hard of hearing patients and families. We service all pediatric and maternity patients, their families and staff in all units, clinics, and services involved in patient care. Our services are available at no charge to the patient or family. Interpretation may be provided in-person, by telephone and/or video, as available. The study contact at will receive further instructions about requesting Interpreter Services upon submission of this survey.
Pharmacy Services Lucile Packard Children's Hospital Stanford Pharmacy department provides all medications required for safe and effective patient care. This includes preparing, dispensing, and distributing drugs in the appropriate form for patient use in clinical research being done at Stanford Children's Health. The department consists of inpatient pharmacy, outpatient pharmacy, and pharmacy services to other ambulatory clinic area.
Please select all locations where participants will receive medication on this study and answer any follow-up questions.
Inpatient pharmacy Services: provides oversight for investigational trials in subjects that are classified as inpatients (i.e. patients admitted to a 24 hour bed) and patients admitted to the Short Stay Unit or Bass Center Day Hospital (i.e. patients admitted for non-oncology IV infusions as an outpatient). This also includes studies conducted at Packard at El Camino (PEC)
Outpatient Investigational pharmacy: Outpatient pharmacists handle investigational trials that enroll patients receiving medications administered at home or in clinic.
Home
Clinic-administered medication
Bass Center Investigational pharmacy: B ass Center pharmacists provide services for subjects enrolled in Hematology/Oncology/Neuro-Oncology/SCT trials. Certification for handling of radiopharmaceuticals by a Bass Center pharmacist is currently not available.
CTRU: Pediatric subjects admitted to CTRU typically receive services from the Stanford Hospital Investigational Drug Service. However, other arrangements can be made to coordinate with outpatient pharmacy services at Stanford Children's Health. By selecting this pharmacy service you will be connected to SCH pharmacist who can help you figure out what pharmacy service works best for your pediatric CTRU study.
Children's Home Pharmacy: the home pharmacy investigational pharmacist will prepare sterile compounded investigational drug infusions for patients managed in the home setting.
Who will supply all medications used in this study? (select all that apply)
How many investigational agents are involved in this study?
Please check all that apply to the investigational drug
Please provide the type of injectable.
SubQ
IM
IV
Unsure
Storage of investigational drug.
Room temperature
Refrigerated/Frozen
Unsure
Please indicate whether the outpatient pharmacy is required to perform compounding of oral pharmaceutical products
Yes
No
Unsure
Indicate what pharmacy assistance you may need to set-up your drug trial:
Upon submission of this survey the study contact at ______ will receive further instructions regarding initiating contact with the following pharmacy service(s):
If this is incorrect, please uncheck or check the correct pharmacy services above.
A procurement fee is applied to investigational drug studies using any of the Stanford Children's Health and LPCH pharmacies: Procurement and handling of medications or supplies: Drug/Supply acquisition cost + 20% surcharge
Research Lab Services: Special Studies in Clinical Labs: The Special Studies team can help collect, process and/or ship tissues(including blood) collected for research purposes at any of the Stanford Children's Health (SCH) or Stanford Health Care (SHC) locations.
Will your study require use of research lab services?
* must provide value
Yes
No
I am unsure
Thank you. The study contact at ______ will receive further instructions upon completion of this form.
If you are unsure, please ask the primary investigator or protocol director for your study. You can also contact the CRSO at crso@stanfordchildrens.org for guidance.
Pediatric Radiology Will you require imaging for your future research project, including Magnetic Resonance Imaging (MRI), Computed Tomography (CT), Ultrasound (US), Nuclear Medicine, fluoroscopy, and/or plain films?
* must provide value
Yes
No
I am unsure
Please select the Pediatric Radiology resources needed:
Thank you. The study contact at ______ will receive further instructions upon completion of this form.
If you are unsure, please ask the primary investigator or protocol director for your study. You can also contact the CRSO at crso@stanfordchildrens.org for guidance.
Stanford Anatomic Pathology & Clinical Laboratories Stanford Anatomic Pathology & Clinical Laboratories provides pathology and laboratory testing services to patients from Stanford Health Care, Stanford Children’s Health and outside institutions.
To review range of services provided by surgical pathology and other affiliated services, please click here: https://stanfordlab.com/
Does your study require tissue for research?
Yes
No
I don't know
If you are unsure, please ask the primary investigator or protocol director for your study. You can also contact the CRSO at crso@stanfordchildrens.org for guidance.
Does your study require fresh tissue?
Yes
No
mm ml g
Describe processing requirements for fresh tissue:
Time frame for processing fresh tissue:
Fresh Tissue Processing requirements: Time-frame for processing:
Does your study require frozen tissue?
Yes
No
mm ml g
Does your study require blocks for research?
Yes
No
What are the processing requirements for block tissues:
Does your study require slides for research?
Yes
No
Unstained Stained Slides Quantity
Are other ancillary pathology services required?
Other ancillary pathology service:
Will you require FFPE blocks and/or slides ?
Yes
No
I am unsure
Please provide additional information on FFPE blocks and/or slides
Thank you. The study contact at ______ will receive further instructions about requesting pathology services upon submission of this survey.
Rehabilitation Services: Occupat ional Therapy, Physical Therapy, Speech and Language Pathology, Motion and Gait Analysis Laboratory (Menlo park) The department of Rehabilitation includes inpatient and outpatient care for children with a wide range of medical conditions. Services that fall under the department of rehabilitation include occupational therapy, physical therapy, speech and language pathology, and motion and gait analysis laboratory (located in Menlo park). For more details, v isit the department page at SCH website: https://www.stanfordchildrens.org/en/service/rehabilitation-services?
Select the rehabilitation service(s) you may need to support your future research project and answer the subsequent questions about what your study team will need from the service:
Occupational Therapy (OT)
Orthopedic and Sports Physical Therapy
Motion Analysis & Sports Performance Laboratory located in Menlo Park
The Outpatient Rehabilitation Center at SCH is a comprehensive therapeutic program for children of all ages outside of a hospital setting.
Complete the table below for ONE study participant:
Time spent on direct patient care for a single study participant: hrs/week Time spent documenting for a single study participant: hrs/week Time spent on research case conference for a single study participant: hrs/week Describe how the clinician will be expected to participate in the study: Describe how a typical week would look for a clinician completing assesments for a single study participant:
How will the clinician's time be funded? Will the clinical assessments done as part of this research study be considered standard of care?
What is the anticipated volume of participants per month? Will rehabilitation services assist in developing research study documentation(e.g. EPIC order sets) ? Explain who will be responsible for scheduling participant study visits:
Hours per week for direct patient care?
hours per week
Hours per week spent on research-only documentation?
hours per week
Hours per week spent on research/case conference time ?
What is the anticipated volume of participants per month?
Please describe how the clinician will be expected to participate in the study:
Describe how a typical week would look for a clinician in your study:
How will the clinician time be funded?
Will the clinical assessments done as part of this research study be considered standard of care?
Yes
No
Will rehabilitation services assist in developing research study documentation(e.g. EPIC order sets) ?
Yes
No
Who will be responsible for scheduling research study visits?
Enter N/A if not applicable to your study.
Is there any specific training or equipment that is required in advance of or for the study?
Yes
No
I am unsure
Provide details on training:
Thank you. The study contact at ______ will receive further instructions about requesting the selected rehabilitation services upon submission of this survey.
Information Services (IS) at Stanford Children's Health Stanford Children's Health (SCH) Information Services (IS) department supports overall clinical & non-clinical technology infrastructure for the smooth and safe functioning of hospital services. If your research study will take place on hospital premises and requires EPIC support (order sets, best practice alerts, etc.) and/or Clinical Technology and Biomedical Engineering (medical devices, patient related equipment, non-Stanford hospital owned devices used to transmit data) then you will likely require a consult with these departments.NOTE: Hospital IS is a separate entity than that of the Stanford University and School of Medicine IT departments. Hospital IS may refer you if appropriate but please check with University and SoM IT to ensure you are complying with institutional policy.
IS Services: Clinical Technology and Biomedical Engineering: (CTBE) Clinical Technology and Biomedical Engineering (CTBE) department promotes safe and effective application of science and technology in patient care at Stanford Children’s Health (SCH). In general, all patient-related medical equipment that is not owned by Stanford Children's Health must be managed in the same way as medical equipment owned by SCH. This includes medical equipment provided for human subjects research. Any medical equipment brought into SCH clinics and hospitals and used as part of a research study must be evaluated for safety by CTBE.
This includes all of the following:
investigational device being studied on your clinical trial, regardless of IDE application and/or FDA determination, including IDE exempt devices. patient-related equipment not being studied and being brought in by the study team to SCH facility as part of the trial. Does your trial involve the use of any of the above medical devices?
Yes, my study involves use of medical devices and/or patient related equipment.
No, my study doesn't use any patient-related medical equipment or devices.
I am unsure
If you are unsure, please ask the primary investigator or protocol director for your study. You can also contact the CRSO at crso@stanfordchildrens.org for guidance.
Is the device FDA approved?
Yes
No
Is the device FDA approved?
Yes
No
Does the device need a network connection?
Yes
No
Does the device need a network connection?
Yes
No
Does the device need integration to other systems?
Yes
No
Does the device need integration to other systems?
Yes
No
Who will maintain/service the device while in use? Please explain.
Who will maintain/service the device while in use? Please explain.
Fill in the following information about the medical device:
Device vendor: Device manufacturer: Model of the device Is the device FDA approved? Does the device need a network connection? Does the device need integration to other systems? Who will maintain/service the device while in use?
Yes
No
Fill in the following information about the medical device:
Device vendor: {device_vendor_2} Device manufacturer: Model of the device Is the device FDA approved? Does the device need a network connection? Does the device need integration to other systems? Who will maintain/service the device while in use?
Do you need data from a certain medical system/device for your study?
Yes
No
The hospital makes regular data transfers to SOM for Research support. We encourage you to contact https://redcap.stanford.edu/plugins/gethelp/ for data requests. In addition, please note that any device that collect, use or store high risk data should consult with Stanford University IT as well: https://uit.stanford.edu/security/dra
Fill out information for the device/system you will need access to:
Vendor: Manufacturer: Model:
What data is required? Please describe:
Do you need access to the system, or just need a download of the data?
I just need access
I just need a download of the data
I need both
Is there another medical system/device that you will need data from for your study?
Yes
No
Fill out information for the device/system you will need access to:
Vendor: Manufacturer: Model:
What data is required? Please describe:
Do you need access to the system, or just need a download of the data?
I just need access
I just need a download of the data
I need both
Thank you. The study contact at ______ will receive further instructions about requesting CTBE services upon submission of this survey.
IS Services: Research IS Team The research IS team can help study teams in determining how the electronic medical record (EPIC) can be leveraged for use in their research project. For example, if your study involves administration of medications, lab draws or other diagnostic tests, you may consider the creation of an order set in EPIC. This will allow your research coordinators the ability to easily place the orders with consistency and accuracy and provide a strong line of communication to the Care Team/Nurses taking care of study participants.
Do you anticipate using the SCH electronic health record, EPIC, system or another Information System (IS) service for your research study?
Yes
No
I am unsure
If you are unsure, please ask the primary investigator or protocol director for your study. You can also contact the CRSO at crso@stanfordchildrens.org for guidance.
Please describe how you plan on using EPIC or another IS service for your study:
Would you like to request a consultation with IS services?
Yes
No
Thank you. The study contact at ______ will receive further instructions about requesting IS services upon submission of this survey.
Interpreter Services Lucile Packard Children’s Hospital Stanford provides efficient, accurate and timely medical interpretation and translation services for all non-English speaking and hard of hearing patients and families. We service all pediatric and maternity patients, their families and staff in all units, clinics, and services involved in patient care. Interpretation may be provided in-person, by telephone and/or video, as available.
Will your study require interpreter services?
* must provide value
Yes
No
Thank you. The study contact at ______ will receive further instructions and pricing information about requesting interpreter services upon submission of this survey.
In the comments box below, please add hospital-based patient care units or clinical and diagnostic services that you require for your future clinical research study but do not see listed (e.g. PICU, Radiology Film Library, Nutrition Services, Nursing etc.):
Thank you. The CRSO team will reach out to the study contact , ______ ______ , at ______ to facilitate communication with these SCH departments.
Please select any of the following School of Medicine resources:
The mission of Office of Community Engaged Research (OCER) is to promote health equity for maternal and child health populations by supporting community-engaged research initiatives and advancing strong collaborative partnerships between community, academic, and policy entities. https://app.smartsheet.com/b/form/7d48678c125c418fbecd9ca2b61b2995
Research Participation services help study teams meet their participant recruitment goals, with a focus on engaging participants as partners in research. To learn more about the different services offered by the Research Participation team, please visit their website at: http://med.stanford.edu/spectrum/b1_8_rec.html
Yes
No
Thank you. The study contact at ______ will receive further instructions about requesting Research Participation services upon submission of this survey.
The following fields are for administrative and document storage use only. File uploads are to be used to document specific agreements or modifications associated to an investigator or project.
IDS Fee Quote & Agreement Form:
IDS Fee Quote Adjustment Form:
Submit
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