Note: This form is provided to preview the questions prior to beginning the online submission process.

REQUEST for PCORnet STUDY DESIGNATION

PCORnet’s study designation may be desirable to reflect the PCORnet brand and its association with high-quality, efficient, and timely people-centered outcomes research. To qualify for PCORnet study designation, a study must:

  1. Be people-centered
  2. Include at least onePCORnet Clinical Data Research Network (CDRN) or Patient Powered Research Network (PPRN)
  3. Use quality-checked data standardized to the PCORnet Common Data Model (CDM)format
  4. Use as many PCORnet resources as possible
  5. Demonstrate how participants/patients are engaged in the design, conduct, analysis, or dissemination of the research.

Please complete this form if you are interested in obtaining PCORnet’s Study Designation. Please contact the PCORnet Front Door if you have any questions

# / Question / Response
1 / Request Date
Principal Investigator / Requester Information
2 / First Name
3 / Last Name
4 / Title
5 / Institution
6 / Email Address
7 / Phone Number
8 / Mailing Address
9 / City
10 / State
11 / Zip Code
12 / Would you like to provide a second contact for correspondence? / Yes
No
If yes, please provide email address
13 / Are you the Lead Site or a Network Site for a PCORnet CDRN (Clinical Data Research Network)?
(LEAD SITE - The organization with a direct or prime, contractual relationship with PCORI (the funder) in support of the Network, OR NETWORK SITE - A healthcare system, integrated delivery system, or academic medical center that has a contractual relationship with the Lead Site in support of the Network, its operation, and data flows.) / Yes
No
If Yes, select your PCORnet CDRN affiliation. / ADVANCE
CAPriCORN
GPC
LHSNet
Mid-South
NYC
OneFlorida
PaTH
PEDSnet
PORTAL
pSCANNER
REACHnet
SCILHS
14 / Are you the Lead Site or an affiliated organization, foundation, or group for a PCORnet PPRN (Patient Powered Research Network)? / Yes
No
If Yes, select your PCORnet PPRN affiliation. / ABOUT
AR-PoWER
CCFA
CENA
Community and Patient-Partnered Centers of Excellence forBehavioral Health
COPD
DuchenneConnect
Health eHeart Alliance
ImproveCareNow
Interactive Autism Network
Mood
Multiple Sclerosis
National Alzheimer’s and Dementia Patient and Caregiver-Powered Research Network
NephCure Kidney Network
PARTNERS
Phelan-McDermid Syndrome Data Network
PI-CONNECT
PRIDEnet
Rare Epilepsy Network
Vasculitis
15 / Is this request from a PCORnet Collaborative Research Group (CRG)? / Yes
No
If yes, select CRG / Cardiovascular Health
Pediatrics
Health Disparities
Other, define:
16 / Is this request from the PCORnet Coordinating Center? / Yes
No
Study Designation Requirements
17 / Are you requesting PCORnet Study designation approval? / Yes
No
If no, are you requesting a Letter of Support from PCORnet? / Yes
No
18 / Is the study Participant/Patient-Centered?
(A research activity is participants/patient-centered if it pursues a question that is important to participants/patients, measures outcomes that are noticeable and meaningful to them, and produces results that help them weigh the value of healthcare options given their personal circumstances, conditions, and preferences.) / Yes
No
If Yes, briefly describe how your study is Participant/Patient-Centered.
19 / Describe how participants/patients are engaged or your intent to engage participants/patients in planning, conducting, and disseminating the research study.
(e.g., In what phases of the project? Are you working with PPRNs? Advocacy groups? Which stakeholders or groups are you/will you be engaging? What components of the research project will you be contributing to? How has/will your study design be modified by the participant/patient engagement?)
Refer to:
20 / Are you including at least 1 PCORnet network (CDRN or PPRN) as part of the investigator team? / Yes
No
21 / Select the CDRNs that will be involved in this project. / N/A
ADVANCE
CAPriCORN
GPC
LHSNet
Mid-South
NYC
OneFlorida
PaTH
PEDSnet
PORTAL
pSCANNER
REACHnet
SCILHS
22 / If a CDRN is selected, describe what role(s) the Network(s) will have. / Co-Investigators
Intervention Sites
Recruitment of participants/patients
Stakeholder engagement
Other role, describe:
23 / Select the PPRNs to be involved in this project. / N/A
ABOUT
AR-PoWER
CCFA
CENA
Community and Patient-Partnered Centers of Excellence forBehavioral Health
COPD
DuchenneConnect
Health eHeart Alliance
ImproveCareNow
Interactive Autism Network
Mood
Multiple Sclerosis
National Alzheimer’s and Dementia Patient and Caregiver-Powered Research Network
NephCure Kidney Network
PARTNERS
Phelan-McDermid Syndrome Data Network
PI-CONNECT
PRIDEnet
Rare Epilepsy Network
Vasculitis
24 / If a PPRN is selected, describe what role(s) the Network(s) will have. / Co-Investigators
Intervention Sites
Recruitment of participants/patients
Stakeholder engagement
Other role, describe:
25 / What site will be the lead site for this study?
26 / Are you planning to use the PCORnet Common Data Model?
Refer to: / Yes
No
If no, please explain why not
Select the following PCORnet resources you plan to use:
27 / • PCORnet query tool
If No, please explain why not.
28 / • PCORnet Single IRB Agreement
If No, please explain why not.
29 / • PCORnet Data Sharing Agreement
If No, please explain why not.
30 / Does this study involve cost-effectiveness research or other cost analysis? / Yes
No
If Yes, please describe.
31 / Tell us more about why this study should be approved.
Funding
32 / How do you anticipate the study will be funded? / PCORI
NIH
Industry
Foundation
Other, describe
33 / Have you already obtained funding? / Yes
No
Project Information
34 / Research Project Title
35 / Type of Study
Intervention Trials, which usually involve randomization at the participant/patient, physician, clinic, hospital, or systems levels, but could use non-random allocation of the intervention.
Retrospective Observational Studies that use existing data in cross-sectional or longitudinal analyses.
Prospective Observational Studies that involve collection of new data. / Intervention Trial
Retrospective Observational Study
Prospective Observational Study
Other, study type, describe:
36 / Area(s) Being Studied
/ Pediatrics
Cardiovascular
Health Disparities
Cancer
Behavioral Health
Gastroenterology
Autoimmune
Neurosciences
Pulmonary
Healthcare Delivery
Obesity/Diabetes
Renal
Rare Diseases, Specify:
Other, Specify:
Study Design
37 / Describe study population
38 / Describe the Primary Aims or research questions to be addressed
39 / Describe the Secondary Aims or research questions to be addressed
40 / Primary Objective
41 / Secondary Objectives
42 / Are you planning an interventional treatment that is assigned by the study team; not chosen by the provider/participant/patient? / Yes
No
If Yes, what type? / Drug
Medical Device
Behavioral
Other, specify
43 / Describe the intervention(s).
44 / Will there be randomized assignment of the intervention? / Yes
No
If Yes, please indicate method of randomization. / Participant/Patient-level
Clustered by healthcare provider
Clustered by other unit
Attestation
Requirements for PCORnet designated studies are policies of the governing PCORnet Council, the governing body of the network, and are intended to assure transparency of our activities and improvement in service to investigators and the public. If this study receives PCORnet study designation, please specify if you agree to comply with the following obligations, as applicable.
45 / Registration with ClinicalTrials.gov for all eligible studies (including clinical trials and observational outcome studies). / Yes
No
46 / Submission of the final analysis files, the final protocol, and two abstracts of no more than 500 words (one for medical professionals and one for a lay audience), to the PCORnet Coordinating Center within 18 months of study completion. Submissions will be posted on the public PCORnet website. / Yes
No
47 / Acknowledgment of the study’s status as a PCORnet study in all websites, reports, presentations, and manuscripts. / Yes
No
48 / Submission of a report on lessons learned from your study’s successes and failures to the PCORnet Coordinating Center within 18 months from the completion of the final analysis files. This report will be deposited in the PCORnet Commons, PCORnet’s resourced tools and resources. / Yes
No
49 / Compliance with PCORnet policies to not sell, or otherwise provide source data or analyzable datasets developed through queries that are issued via PCORnet, to third parties unless they are being shared for a pre-specified and PCORnet-approved research use. Research data collected specifically for this study and not issued via PCORnet are exempt from this provision. / Yes
No
Note: PCORnet studies are not required to seek approval for publications or presentations from the PCORnet Council or any of its standing Committees.
50 / Please provide any other details about your request.
51 / I understand that this information will be provided to the PCORnet Research Committee for review purposes and my answers will not be forwarded to the study section evaluating scientific merit. / Yes
No

V. 6/30/2016