Parkland Performance Site Review Form

Instructions for completing this form.

eIRB Study Number

STU-

Study Principal Investigator (PI):

First Name 

Last Name 

Principal Investigator Contact Information

First Name: ______        Last Name: ______

Credentials:

Department:

Email:

Pager:

Phone number:

Mail Code:

* must provide value

Primary Research Coordinator Contact Information

First Name:

Last Name:

Email:

Phone number:

Pager:

* must provide value

Regulatory Contact Information

First Name:

Last Name:

Email:

Phone:

Administrative Contact Information

First Name:

Last Name:

Email:

Phone Number:

Financial Contact Information

First Name:

Last Name:

Email:

Phone:

Sponsor Contact Information

Primary Sponsor Company Name:

First Name:

Last Name:

Email

Phone

By selecting this study as DATA ONLY, you are confirming the following Parkland ancillary services are not required or other activities will not take place.

An additional service has been selected above and will be required for this study. Therefore, this study is not considered "Data Only" at Parkland. Please select "Data Only" as "no" and then the "Resources" study activity as "yes".

By selecting "Survey", please ensure you are selecting the appropriate responses to the Recruitment and Resources study activities above if required at Parkland.

By selecting "Focus Groups", please ensure you are selecting the appropriate responses to the Recruitment and Resources study activities above if required at Parkland.

Please read and acknowledge the acceptable in-person recruitment method at Parkland provided below. For more information, please see attached policy.

Once patients are identified, the researcher(s) should contact the patient’s care provider or another member of the clinical care team to tell them about the study. The care provider or member of the clinical care team, in turn, can mention the study to the patient or Legally Authorized Representative (LAR). If the patient or LAR agrees, the member of the clinical care team can pass on the patient information to the researcher(s). The researcher(s) can then contact the patient or LAR to discuss the study. Researchers cannot contact patients or LARs directly without going through the patient’s clinical care team first and the patient or LAR approving the contact.

Although UTSW allows the "cold calling" method, this is not an acceptable recruitment method at Parkland.

Please read and acknowledge the acceptable recruitment method via mail or telephone at Parkland provided below. For more information, please see attached policy.

If potential subjects are not currently under the care of the study PI or Co-I(s), in order to recruit Parkland patients via telephone/mail for this study, a research invitation/recruitment letter will be required to be sent to the potential subject prior to any telephone contact made. The letter should include the Parkland logo and will need to be signed by the Parkland medical director of the clinic potential participants will be recruited from, if the medical director agrees. The PI's signature must also be contained in the letter. Potential subjects should have the ability to opt-out or opt-in prior to a telephone call from the study team. Therefore, please be sure to include an appropriate phrase stating this within letter. There should be contact information, including a phone number, of the study team provided in the letter and on the information sheet. A maximum of three phone call attempts across two weeks can be made to contact the potential subject after the invitation letter has been sent.

Although UTSW allows the "cold calling" method, this is not an acceptable recruitment method at Parkland.

For email recruitment, an email template and information sheet must be available for potential participants.

Study team members may not directly email PHHS employees or colleagues for study recruitment. Please ensure that the protocol and Form C have an adequate email recruitment plan for Parkland.  

Please confirm that Parkland is named, and various required consent language is included in appropriate areas of the consent form in order to recruit Parkland patients. Please see the informed consent required language document attached below.

• PHHS is named in the header on the first page of the form. 
• Injury clause language included. 
• PHHS or Parkland research office named in PHI section. 
• Parkland named in the voluntary participation section. 

Please note that if any of the above required language is not included in the consent form, a modification to inlcude the language in the consent form will be required.

Please note that a fully translated Spanish consent form or information sheet must be available and approved by the IRB before Parkland ORA will provide study site approval.  If this study includes participant forms and/or surveys, these documents will also require translation to Spanish.

1. If you are needing assistance, UTSW IRB has a vendor that you can contact to complete this process.  Please submit a mod in eIRB when translation is complete and send me an e-mail when the mod has been submitted
2. A Professional Medical Interpreter (Language Assistants/Patient Interpretation Representatives) qualified in the subjects’ language and English must be provided by the study team to facilitate informed consent and other study activities. Unless, a member of the study team is Spanish speaking and will be able to provide interpretation. If this is the case, certification will be required.
3. All Language Video Interpreter Network (ALVIN) - 214-590-5846 or 2-5846 if calling internal at PHHS.

Information on requesting translation services from UTSW HRPPO.

Form Z - Translation Request document. Must be submitted to the UTSW HRPPO. Please see above document.

Inpatient Research Locations

Please specify ALL Parkland Inpatient locations where study activities will take place:
Please specify the inpatient unit floors where study activities will take place:

Briefly explain what study activities will take place in the above selected Parkland patient care area(s).

Emergency Services Research Locations

Please specify all Parkland Emergency Services areas where study activities will take place.

Briefly explain what study activities will take place in the above selected Parkland patient care area(s).

Jail Health Research Location

Specify name(s) of Jail Health Center(s) involved:

Briefly explain what study activities will take place in the above selected Parkland patient care area(s).

Outpatient Specialty Clinic Research Locations

Please select ALL Parkland hospital specialty clinics involved.

Briefly explain what study activities will take place in the above selected Parkland patient care area(s).

COPC Research Locations

Select COPC population Involved.

Please select ALL Parkland COPCs involved.

Briefly explain what study activities will take place in the above selected Parkland patient care area(s). 

Youth and Family Center Research Locations

Please select ALL Youth and Family Centers involved.

Briefly explain what study activities will take place in the above selected Parkland patient care area(s).

WISH Research Locations

Please select ALL WISH Specialty Clinics and Women and Infant Services involved.

Briefly explain what study activities will take place in the above selected Parkland patient care area(s).

Please list the device(s) being studied, the device type and device identification number. Information for at least one device must be completed below in order to submit this form.

1. Device:

    Device Type:

    Device ID#:

2. Device:

    Device Type:

    Device ID#:

3.  Device:

     Device Type:

     Device ID#:

 Co-Investigator 1 

First Name:

Last Name:

Please select current credentials:
Does this individual have medical privileged at Parkland to conduct research interventions as indicated in the IRB approved protocol? *Please note that Parkland ORA will be verifying medical privileges.

Please contact the Parkland Medical Staff Office for assistance and credentialing provider information.

PHHS MEDICAL AFFAIRS < MEDICAL.AFFAIRS@phhs.org>

 Co-Investigator 2 

First Name:

Last Name:  

Please select current credentials:
Does this individual have medical privileged at Parkland to conduct research interventions as indicated in the IRB approved protocol? *Please note that Parkland ORA will be verifying medical privileges.

Please contact the Parkland Medical Staff Office for assistance and credentialing provider information.

PHHS MEDICAL AFFAIRS < MEDICAL.AFFAIRS@phhs.org>

 Co-Investigator 3 

First Name:

Last Name:

Please select current credentials:
Does this individual have medical privileged at Parkland to conduct research interventions as indicated in the IRB approved protocol? *Please note that Parkland ORA will be verifying medical privileges.

Please contact the Parkland Medical Staff Office for assistance and credentialing provider information.

PHHS MEDICAL AFFAIRS < MEDICAL.AFFAIRS@phhs.org>

 Co-Investigator 4 

First Name:

Last Name:

Please select current credentials:
Does this individual have medical privileged at Parkland to conduct research interventions as indicated in the IRB approved protocol? *Please note that Parkland ORA staff will be verifying medical privileges.

Please contact the Parkland Medical Staff Office for assistance and credentialing provider information.

PHHS MEDICAL AFFAIRS < MEDICAL.AFFAIRS@phhs.org>

 Co-Investigator 5 

First Name:

Last Name:

Please select current credentials:
Does this individual have medical privileged at Parkland to conduct research interventions as indicated in the IRB approved protocol? *Please note that Parkland ORA will be verifying medical privileges.

Please contact the Parkland Medical Staff Office for assistance and credentialing provider information.

PHHS MEDICAL AFFAIRS < MEDICAL.AFFAIRS@phhs.org>

Study Personnel 1

First Name:

Last Name:
Home Affiliated Institution:
Is this individual a licensed professional?
Check ALL research activities that will be performed at Parkland by this individual for this research study specifically.

NOTE:  If performing any task at Parkland such as phlebotomy, EKG, or medication administration (RN only), the employee MUST provide the ORA with training documentation for these tasks PRIOR to performing the task at Parkland (see the Parkland Credentialing Instructions for more details.

Study Personnel 2

First Name:

Last Name:
Home Affiliated Institution:
Is this individual a licensed professional?
Check ALL research activities that will be performed at Parkland by this individual for this research study specifically.

NOTE:  If performing any task at Parkland such as phlebotomy, EKG, or medication administration (RN only), the employee MUST provide the ORA with training documentation for these tasks PRIOR to performing the task at Parkland (see the Parkland Credentialing Instructions for more details.

Study Personnel 3

First Name:

Last Name:
Home Affiliated Institution:
Is this individual a licensed professional?
Check ALL research activities that will be performed at Parkland by this individual for this research study specifically.

NOTE:  If performing any task at Parkland such as phlebotomy, EKG, or medication administration (RN only), the employee MUST provide the ORA with training documentation for these tasks PRIOR to performing the task at Parkland (see the Parkland Credentialing Instructions for more details.

Study Personnel 4

First Name:

Last Name:
Home Affiliated Institution:
Is this individual a licensed professional?
Check ALL research activities that will be performed at Parkland by this individual for this research study specifically.

NOTE:  If performing any task at Parkland such as phlebotomy, EKG, or medication administration (RN only), the employee MUST provide the ORA with training documentation for these tasks PRIOR to performing the task at Parkland (see the Parkland Credentialing Instructions for more details.

Study Personnel 5

First Name:

Last Name:
Home Affiliated Institution:
Is this individual a licensed professional?
Check ALL research activities that will be performed at Parkland by this individual for this research study specifically.

NOTE:  If performing any task at Parkland such as phlebotomy, EKG, or medication administration (RN only), the employee MUST provide the ORA with training documentation for these tasks PRIOR to performing the task at Parkland (see the Parkland Credentialing Instructions for more details.

Study Personnel 6

First Name:

Last Name:
Home Affiliated Institution:
Is this individual a licensed professional?
Check ALL research activities that will be performed at Parkland by this individual for this research study specifically.

NOTE:  If performing any task at Parkland such as phlebotomy, EKG, or medication administration (RN only), the employee MUST provide the ORA with training documentation for these tasks PRIOR to performing the task at Parkland (see the Parkland Credentialing Instructions for more details.

Study Personnel 7

First Name:

Last Name:
Home Affiliated Institution:
Is this individual a licensed professional?
Check ALL research activities that will be performed at Parkland by this individual for this research study specifically.

NOTE:  If performing any task at Parkland such as phlebotomy, EKG, or medication administration (RN only), the employee MUST provide the ORA with training documentation for these tasks PRIOR to performing the task at Parkland (see the Parkland Credentialing Instructions for more details.

   Study Personnel 8  

First Name:

Last Name:
Home Affiliated Institution:
Is this individual a licensed professional?
Check ALL research activities that will be performed at Parkland by this individual for this research study specifically.

NOTE:  If performing any task at Parkland such as phlebotomy, EKG, or medication administration (RN only), the employee MUST provide the ORA with training documentation for these tasks PRIOR to performing the task at Parkland (see the Parkland Credentialing Instructions for more details.

Study Monitor Contact Information

Company Name:

First Name:

Last Name:

Email:

Phone:

Back-Up Coordinator Contact Information

First Name:

Last Name:

Email:

If yes, how many blood draws and what is the time frame?

Number of pk blood draws:

Time frame for pk draws:

If requesting or retrieving Parkland patient data (other than radiographic images), please complete the Parkland Research Data REDCap Survey at https://redcap.link/parkland.research.data.

*This form is required for study teams pulling their own data or using a non-ORA analyst in addition to those that are requesting data from the ORA. For teams not using ORA data services, the purpose of this form is to ensure alignment between data being retrieved and the study protocol/eIRB submission in order to protect study teams, Parkland, and our patients. Parkland Site Review approval will not be finalized until the Parkland Research Data survey has been submitted.

Please note that only radiologists have access to iPACS. Copies of images from PACS/ radiology systems cannot be downloaded and/ or deidentified by the study team directly due to HIPAA regulations at Parkland. Therefore, copies of images must be provided by Parkland Research Radiology Administration.

Printed Name of Person Completing Form
First Name:
Last Name: