Getting started at the Seattle Children's PCRC

Please review the Protocol Implementation in the Pediatric Clinical Research Center (PCRC)
Flow Sheet.
 

1) Submit the application for review

Obtain and complete the PCRC application including relevant appendices and service supplement, and review the PCRC application checklist (.doc).  The PCRC requires copies of all documents that are submitted to the IRB (now and any modifications in the future). A complete submission to the Pediatric Scientific Research Committee (PSRC), at a minimum, requires:

1. Complete Children's IRB-ITHS Application including ITHS Service Supplement long form or short form, and all relevant appendices 3-8.  For any questions related to Children’s IRB-ITHS Application, please visit Children’s IRB website.
2. Protocol (see simple example of protocol)
3. Data Safety and Monitoring Plan (DSMP) Form
4. Consent/assent form(s) (current drafts acceptable)
5. HIPAA authorization
6. Prior Scientific Review Form and supporting documentation for studies that have already undergone a rigorous scientific review by an approved External Scientific Review Committees (ESRC) and are requesting a waiver of formal review by the PSRC. Note: All submissions still undergo reviews by core managers for utilization, resources review and feasibility.
7. CV of the Principal Investigator (if new to the PCRC)

Submit the application electronically to PediatricCRC-ITHS@seattlechildrens.org by the 10th of the month. Applications are reviewed at the following monthly SRC meeting. The Pediatric SRC meets the first Thursday of each month. For example, a complete application received by the 10th of March 2009 would be reviewed at the meeting on the first Thursday of the following month: April 2, 2009.

IRB approval is not necessary prior to submitting to ITHS; however, final IRB approval is necessary before study implementation in the PCRC. To save you time in approval processes, we recommend that applications go through the PSRC first or simultaneously with IRB. Both committees use a pre-review process and each committee can request changes to the application.

Use of ITHS resources requires:

1. Every Active Collaborator (see definition below) listed on the IRB-ITHS application must have an eRA Commons User Name.  This is mandated by NIH/NCRR for the annual progress report (APR).  If you do not have an eRA Commons User Name, please request that one be created for you by emailing: PediatricCRC-ITHS@seattlechildrens.org. 
2. Every Active Collaborator listed on the IRB-ITHS application are required to submit their UW Net ID or a Protect Net ID in order to access the ITHS Central Data Base and update profiles required by NIH-NCRR APR.  Please forward your appropriate ID address to PediatricCRC-ITHS@seattlechildrens.org – Once your ID is entered into the ITHS Central Data Base (CDB) you can update your profile by going to the CDB website:  cdb.iths.org.  Please forward your UW ID Net or Protect Net ID, or if you need assistance applying for a free Protect Net ID, please contact PediatricCRC-ITHS@seattlechildrens.org.

Once your complete application is submitted, you will receive notification that your study will undergo a pre-review prior to formal review by the SRC. The PCRC Medical Director, administrative manager, and other pre-reviewers may forward any comments, clarifications, or questions to you during this pre-review process. The application may be revised during this time.

Note Definitions:

Active Collaborator:

An “Active collaborator" is defined as "investigator(s) who have significant input into study design and conduct and/or have shared responsibility and accountability for the protocol."  Active Collaborators are considered as “Reportable” (see definition below) under the NIH-NCRR guidelines.

Reportable: 

“An investigator or user is considered reportable to the NIH /if his or her research directly benefited and was advanced by utilizing ITHS supported resources (e.g. PCRC) OR he or she served as a mentor for a research study. ITHS resources include material benefits (e.g., pilot funding, clinic or laboratory space), intellectual contributions (e.g., consultation) or personnel support services (e.g., nursing, nutrition, CRA support)”.  Training of an investigator that does not directly benefit his/her research is not reportable.

2) Await application review and approval

The primary reviewer, who is a member of the PSRC, is assigned by the chairperson to review your study and will conduct a rigorous review of your application and supplemental documents to ascertain:

• Scientific merit
• Compliance with current ethical standards for human subjects’ research
• Feasibility

This review is documented along with the final reviews by the PCRC Nurse Manager, Research Subject Advocate, Biostatistician, and Research Program Manager. Their reviews are presented to the full PSRC and voted upon at the PSRC meeting.

You will receive a letter within one week after the PSRC formal review notifying you of the PSRC’s decision: approved, approved with contingencies, tabled, and disapproved. Additionally, this letter may include post-approval clarifications and/or further recommendations. Read for more details regarding these possible PSRC decisions. The letter will give you details about what is needed based on the outcome of the PSRC review. You may be required to respond to contingencies and/or any clarifications posed by the reviewers. Some comments may be given as recommendations only and will not require responses.

3) Submit  any post-review changes

You must submit to the PSRC a point-by-point response to contingencies or clarifications within 90 days, or your application must be resubmitted. This is sent via the administrative assistant by way of a Memorandum addressed to the chairperson.  These responses along with a revised application (with any changes highlighted) are forwarded to each reviewer that posed the contingencies/clarifications for re-review and approval of the responses.

4) Implementing your study in the PCRC

After approval is received by the appropriate reviewers, an award letter is sent. The award letter will detail what is required and indicate if there are outstanding issues before a Protocol Implementation Meeting (PIM) may be scheduled with the primary PCRC nurse assigned to your study. You will receive guidelines attached to the award letter. If there are still pending clarifications, these will need to be answered. A final review and approval must also be conducted by the Regulatory Support and Bioethics (RSB) staff.You will receive an email when this has been completed and all requirements are met and you are ready to implement your study.

Before implementing your study in the PCRC you will also need to know the following additional information:

Budgets/Grants/Contracts

• Grants and contracts submitted after 02/05/2008 are required to cost share for PCRC resources. Budgets are created by the Office of Sponsored Research (OSR); Clinical Research Budget Analysts (CRBA) CRBA@seattlechildrens.org
• Rates are determined by reviewing your protocol and determining the Level of visit complexity. The Level of visit charged will be determined by the CRC Nurse assigned to the visit and will be based on “real time”. Changes to the budgeted Level will be signed off by the CRC Nurse and will indicate a reason for the change in the Level of visit.
• You may qualify for subsidies for cost sharing. Please see Study Category Guidelines.
• Grants and contract submitted prior to 02/05/08 are grandfathered in and currently the study is not required to cost share. However, the grace period is a limited time period and will end, but sufficient time will be given to investigators for notification that the study is required to cost share for ongoing study visits conducted in the PCRC. In addition, if you have any modifications to the original grandfathered study, you will be required to cost share for the additional resources.
• Effective 1/1/09 the PCRC will no longer approve ancillaries requests. All ancillaries need to be paid by your study budget. Ancillaries are described as any additional or supplementary procedures or supplies to include labs, meal tickets, or study specific supplies.  If you have any questions regarding ancillaries please contact PediatricCRC-ITHS@seattlechildrens.org
• Standard nursing supplies are included in the per visit charge. If there are study specific supplies, the costs will be charged to the study budget.
• A copy of the final approved budget is required. Please submit a copy of your final budget and Lawson Activity Number (LAN). Please contact PediatricCRC-ITHS@seattlechildrens.org, Research Program Manager  if there are any questions regarding billing matters.
• If there are billing events or you are utilizing the PCRC, your study must have a Study Code that you choose and created by the Office of Sponsored Research (OSR) Clinical Research Budget Analysts CRBA@seattlechildrens.org.
• A copy of the Research Study Activation Notice (RSAN) is required. The RSAN informs everyone that your study has been IRB approved, executed grant/contract is in place, and budget and the Lawson Activity Number (LAN) is set up.

Regulatory

• Provision of all IRB approved regulatory documents and Regulatory Support & Bioethics (RSB) core review and approval of these documents. If you have questions regarding the status of your review, please contact Jason Malone, Clinical Compliance Officer.

Nursing/Scheduling

• Completion of the Protocol Implementation Meeting (PIM) and resolution of any nursing outstanding issues.
• Protocols involving DXA scans require Radiation Safety Committee approval before beginning the study.
• Please schedule research subject visits as far in advance as possible. This can be arranged through the PCRC Family Services Representative (FSR), Debbie DePuy at crc.scheduling@seattlechildrens.org.

Psychometry Core Services

• Protocols involving a Psychometry services should involve discussions with the CRC Psychologist and/or Lead Psychometrist.  Please contact Dr. David Breiger at david.breiger@seattlechildrens.org  or Alison Paolozzi at Alison.paolozzi@seattlechildrens.org as far in advance as possible to assist with this requirement.  Please complete Appendix 6.  Note that the PCRC video records Bayley and Mullen Scale Psychometry visits for Quality Assurance in reporting measures is strongly recommended. The request to video tape must be on the IRB-ITHS application in order to obtain IRB approval and therefore must also be included in the Consent/Assent forms.

Annual reporting requirements

• It is a requirement of NIH, and therefore the PCRC, that all publications resulting from studies conducted on the UW or Seattle Children’s CRC units acknowledge that the research was: “Supported, In Part, by NIH Grant UL1 RR025014-XX of the University of Washington - Institute of Translational Health Sciences”.
• You (as well as other research study collaborators named in the application) will be contacted by PCRC staff annually to provide information for an Annual Progress Report to NIH/NCRR. This may include study progress, publications, all federal funding and other support, bio-sketches, etc. We appreciate your assistance.
• Approval for all PCRC resources is contingent upon PCRC annual funding and staffing.