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  • ORCA Admin Function - Enter Information into Agreement Tables
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  • Login to ORCA - https://vpr.uthscsa.edu/orca/

  • Click on ORCA Administration

  • Click on Database Maintenance

  • Click on Agreements

  • Follow the instructions listed below based on the type of agreement.

    • Broad Internal
    • Broad External
    • SS Internal
    • SS External
    • Reciprocal

A broad uni-directional agreement where another organization relies on a HSC committee or board (Broad Internal)

 

  1.     Open the Institution lookup table.
    1. Click Add Record.
    2. ID: acronym of organization
    3. Name: full name of organization
    4. Address: contact person and mailing address
    5. Phone: phone number
    6. FWA: if the organization has a FWA number, enter it here
    7. Active: True
    8. Click Submit
  2.    Open the Agreement table.
    1. Click Add Record.
    2. Agreement name: INT [IRB or IACUC] [acronym of organization]
      1.    Examples: ‘INT IRB SHRC’ or ‘INT IACUC TBRI’
    3. Reliance name: Broad Internal.
    4. Committee: IRB or IACUC
    5. Status: Active
    6. Start date is the date the agreement was signed.
    7. Expire date is the date the agreement will expire per the agreement.
      1.     If no expiration leave blank.
    8. Relying institution: Insert the official name of the organization as it appears on the agreement; Always an organization other than the HSC
    9. When: Select “Always” if the scope of the agreement is checked “all”; otherwise select “Sometimes”.
      1.      Indicates the scope of the broad agreement – For Broad Internal – this field distinguishes whether the relying organization can be selected as a study site for any protocol being submitted for HSC IRB approval (Always) or only when specific criteria are met (Sometimes). 
    10. Following HSC: Select “Yes” if the agreement states in the background section that the relying institution can “rely on external [committees] designated by UTHSCSA”.
      1.      Applicable only to Broad Internal agreements. 
      2.      Indicates whether the relying institution elected to use any External committee that the HSC chooses to use.  (Example: In the Broad Internal agreement with UHS – in addition to using the HSC IRBs, UHS elects to use any external IRB (e.g., WIRB) that the HSC uses)
    11. Regulatory engaged: N/A
    12. Reviewing Committee: the UTHSCSA committee
    13. Reciprocal Institution: N/A
    14. Active: True
    15. Click Submit

 

 

A broad uni-directional agreement where the HSC relies on another organization’s committee or board (Broad External)

 

  1.      Open the Reviewing Committee Lookup table
    1. Click Add Record.
    2. Name: shortened name of organization or acronym
    3. Description: full name of organization
    4. Address: contact person and mailing address
    5. Phone: phone number
    6. Active: True
    7. Click Submit.
  2.     Open the Committee Lookup table
    1. Click Add Record.
    2. Code: shortened name of organization or acronym
    3. Name: full name of organization
    4. Description
    5. Address
    6. Phone
    7. Reliance ID: Broad External
    8. Active: True
    9. Click Submit
  3.     Open the Agreement table.
    1. Click Add Record.
    2. Agreement name: EXT IRB HSC
    3. Reliance name: Broad External.
    4. Committee: IRB or IACUC
    5. Status: Active
    6. Start date is the date the agreement was signed.
    7. Expire date is the date the agreement will expire per the agreement.
      1.           If no expiration leave blank.
    8. Relying institution: UT Health Science Center
    9. When: Some studies.
      1.         Indicates the scope of the broad agreement – - For Board External – this field distinguishes when the HSC will rely on an external committee.  Since the HSC has an internal committee for all currently needed regulatory committees, our use of external committees is limited to Sometimes.  There may come a time when the HSC uses an external committee Always.
    10. Following HSC: N/A.
    11. Regulatory engaged: N/A
    12. Reviewing Committee: Select the record you created in the Reviewing Committee table.
    13. Reciprocal Institution: N/A
    14. Active: True

 

A single-study uni-directional agreement where another organization relies on a HSC committee or board (SS Internal)

 

  1. Open the Institution lookup table.
    1. Click Add Record.
    2. ID: acronym of organization
    3. Name: full name of organization
    4. Address: contact person and mailing address
    5. Phone: phone number
    6. FWA: if the organization has a FWA number, enter it here
    7. Active: True
    8. Click Submit
  2.    Open the Agreement table.
    1. Click Add Record.
    2. Agreement name: SS-INT [IRB or IACUC] [acronym of organization]
      1.     Example: ‘SS-INT IRB MAMC’
    3. Reliance name: Single Study Internal.
    4. Committee: IRB or IACUC
    5. Status: Active
    6. Start date is the date the agreement was signed.
    7. Leave the expire date blank.
      1.     This agreement will expire when the protocol is inactivated.
    8. Relying institution: Insert the official name of the organization as it appears on the agreement; Always an organization other than the HSC
    9. When: Select “Sometimes”
    10. Following HSC: N/A
    11. Regulatory engaged: N/A
    12. Reviewing Committee: the UTHSCSA committee
    13. Reciprocal Institution: N/A
    14. Active: True
    15. Click Submit

 

A single-study uni-directional agreement where the HSC relies on another organization’s committee or board (SS External)

 

  1. Open the Reviewing Committee Lookup table
    1. Click Add Record.
    2. Name: shortened name of organization or acronym
    3. Description: full name of organization
    4. Address: contact person and mailing address
    5. Phone: phone number
    6. Active: True
    7. Click Submit.
  2. Open the Committee Lookup table
    1. Click Add Record.
    2. Code: shortened name of organization or acronym
    3. Name: full name of organization
    4. Description
    5. Address
    6. Phone
    7. Reliance ID: Broad External
    8. Active: True
    9. Click Submit
  3. Open the Agreement table.
    1. Click Add Record.
    2. Agreement name: SS-EXT IRB HSC
    3. Reliance name: Single Study External.
    4. Committee: IRB or IACUC
    5. Status: Active
    6. Start date is the date the agreement was signed.
    7. Leave the expire date blank.
      1.   This agreement will expire when the protocol is inactivated.
    8. Relying institution: UT Health Science Center
    9. When: Some studies.
    10. Following HSC: N/A.
    11. Regulatory engaged: N/A
    12. Reviewing Committee: Insert the name of the committee as it appears on the agreement.
    13. Reciprocal Institution: N/A
    14. Active: True

 

Bi-directional (reciprocal) agreement applicable to more than one protocol

Two records will be created in the Agreement table: Broad Internal and Broad External.

Broad Internal

  1. Open the Institution lookup table.
    1. Click Add Record.
    2. ID: acronym of organization
    3. Name: full name of organization
    4. Address: contact person and mailing address
    5. Phone: phone number
    6. FWA: if the organization has a FWA number, enter it here
    7. Active: True
    8. Click Submit
  2. Open the Agreement table.
    1. Click Add Record.
    2. Agreement name: INT [IRB or IACUC] [acronym of organization]
      1.      Examples: ‘INT IRB UTSA’
    3. Reliance name: Broad Internal.
    4. Committee: IRB or IACUC
    5. Status: Active
    6. Start date is the date the agreement was signed.
    7. Expire date is the date the agreement will expire per the agreement.
      1.       If no expiration leave blank.
    8. Relying institution: Insert the official name of the organization as it appears on the agreement; Always an organization other than the HSC
    9. When: Select “Always” if the scope of the agreement is checked “all”; otherwise select “Sometimes”.
      1.      Indicates the scope of the broad agreement – For Broad Internal – this field distinguishes whether the relying organization can be selected as a study site for any protocol being submitted for HSC IRB approval (Always) or only when specific criteria are met (Sometimes). 
    10. Following HSC: Select “Yes” if the agreement states in the background section that the relying institution can “rely on external [committees] designated by UTHSCSA”.
      1.         Applicable only to Broad Internal agreements. 
      2.        Indicates whether the relying institution elected to use any External committee that the HSC chooses to use.  (Example: In the Broad Internal agreement with UHS – in addition to using the HSC IRBs, UHS elects to use any external IRB (e.g., WIRB) that the HSC uses)
    11. Regulatory engaged: N/A
    12. Reviewing Committee: the UTHSCSA committee
    13. Reciprocal Institution: N/A
    14. Active: True
    15. Click Submit

Broad External

  1. Open the Reviewing Committee Lookup table
    1. Click Add Record.
    2. Name: shortened name of organization or acronym
    3. Description: full name of organization
    4. Address: contact person and mailing address
    5. Phone: phone number
    6. Active: True
    7. Click Submit.
  2. Open the Committee Lookup table
    1. Click Add Record.
    2. Code: shortened name of organization or acronym
    3. Name: full name of organization
    4. Description
    5. Address
    6. Phone
    7. Reliance ID: Broad External
    8. Active: True
    9. Click Submit
  3. Open the Agreement table.
    1. Click Add Record.
    2. Agreement name: EXT IRB HSC
    3. Reliance name: Broad External.
    4. Committee: IRB or IACUC
    5. Status: Active
    6. Start date is the date the agreement was signed.
    7. Expire date is the date the agreement will expire per the agreement.
      1.        If no expiration leave blank.
    8. Relying institution: UT Health Science Center
    9. When: Some studies.
      1.     Indicates the scope of the broad agreement – - For Board External – this field distinguishes when the HSC will rely on an external committee.  Since the HSC has an internal committee for all currently needed regulatory committees, our use of external committees is limited to Sometimes.  There may come a time when the HSC uses an external committee Always.
    10. Following HSC: N/A.
    11. Regulatory engaged: N/A
    12. Reviewing Committee: Select the record you created in the Reviewing Committee table.
    13. Reciprocal Institution: Select the organization that hosts the reviewing committee.
    14. Active: True
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