The Clinical Sequencing Exploratory Research (CSER Phase 1) consortium and Clinical Sequencing Evidence-Generating Research (CSER Phase 2) consortium has produced a vast amount of publications and materials from their studies. Below are the research materials that CSER have shared with the research community.
CSER Phase 2 Harmonized Measures
Adult Measures
- Baseline Measures
- Post Return of Results Follow-up #1 (0-4 weeks after RoR)
- Post Return of Results Follow-up #2 (5-7 months after RoR)
- Decliner Survey
Parental Measures
- Baseline Measures
- Post Return of Results Follow-up #1 (0-4 weeks after RoR)
- Post Return of Results Follow-up #2 (5-7 months after RoR)
- Decliner Survey
Organizational Readiness to Change
Provider Measures
Spanish Adult Measures
- Baseline Measures
- Post Return of Results Follow-up #1 (0-4 weeks after RoR)
- Post Return of Results Follow-up #2 (5-7 months after RoR)
- Decliner Survey
Spanish parental Measures
- Baseline Measures
- Post Return of Results Follow-up #1 (0-4 weeks after RoR)
- Post Return of Results Follow-up #2 (5-7 months after RoR)
- Decliner Survey
CSER Phase 2 Validation Templates
Below you will find templates generated by the CSER validation team. These templates go into detail about the origins of the harmonized measures chosen for our work, and changes made to them to address individual study needs. Information in these templates include: original citation, related citations, description of operational construct, scoring instructions and cut points, and evidence of reliability and validity, as well as other information.
Baseline Measures
Follow-up Measures (RoR FU1/2)
|
Measure name |
Link |
| Feelings about Return of Genomic Results (FACToR) | https://docs.google.com/document/d/181acmRjKFrH1QOLZqc_dJLuAHS5_n-tsk4kd... |
| Information seeking (Adult & Parent) | https://docs.google.com/document/d/1gSWtA_TB7oTAWby59ClPPRPRmgdV4xBRyFQL... |
| Recommended Medical Actions and Follow Through on Recommendations Attributable to Genomic Testing (MRA) | https://docs.google.com/document/d/1PLudTOKUTI94ZKNm2TKju-4JdWC660G5Gf3d... |
| Patient-Initiated Actions Attributable to Genomic Testing (PIA) | https://docs.google.com/document/d/1PZZiTgtLHMGiAVZoCiyZpQ4yfdvAOhlY6Um-... |
| Patient reported utility (PRU) | https://docs.google.com/document/d/1RdvcNrKoJ1y9lO9hvgjiXyVwmYEcAOYeEAnR... |
| QOL SF-12 | https://docs.google.com/document/d/1Sc631D2_Mf302wzfNTQmVaQRCd5kjWEmhZ14... |
| Understanding (Adult & Parent) | https://docs.google.com/document/d/1yayplYWOMuO3oNy78pNF-90qiqZPHxmY8F2L... |
CSER Phase 1 Participant Consent Forms
Baylor College of Medicine
- Patient Consent Form
- Patient Consent Form (Spanish Version)
- Physician Consent Form
- Parent Consent Form
- Parent Consent Form (Spanish Version)
- Age of Majority Consent Form
Brigham & Women's Hospital
- Cardiologist Consent Form
- Primary Care Physician Consent Form
- Patient Consent Form (Cardiology)
- Patient Consent Form (Primary Care Physician)
Children's Hospital of Philadelphia
ClinSeq
Dana-Farber Cancer Institute
Kaiser Permanente
HudsonAlpha
University of Michigan
University of North Carolina
- Parental Consent for Child Relatives of an study participant to test for a specific variant
- Assent Form: (Ages 7-14) Relatives of an study participant to test for a specific variant
- Assent Form: (Ages 15-17) Relatives of an study participant to test for a specific variant
- Consent for Adult Relatives of an study participant to test for a specific variant
University of Washington
CSER Phase 1 Participant Education Materials
Baylor College of Medicine
- Study Brochure
- Study Borchure (Spanish Version)
- Genetic Information Nondiscrimination Act (GINA) Document
- GINA Document (Spanish Version)
- Tumor Mutation Explanation Card
- Tumor Mutation Explanation Card (Spanish Version)
- Inherited Mutation Explanation Card
- Inherited Mutation Explanation Card (Spanish Version)
- X-Linked Explanation Card
- X-Linked Explanation Card (Spanish Version)
- Revised Carrier Status Explanation Card
- Revised Carrier Status Explanation (Spanish Version)
ClinSeq
Dana-Farber Cancer Institute
University of Michigan
University of North Carolina
University of Washington
CSER Phase 1 Protocol and Research Resources
Baylor College of Medicine
- Germline Requisition Document
- Study Questionnaires for Primary or Secondary parent completing for themselves
- Study Questionnaires for Primary or Secondary parent completing for themselves (Spanish Version)
- Family history questionnaire for primary parent
- Family history questionnaire for primary parent (Spanish Version)
- Study questionnaire for primary parent completing for child
- Study questionnaire for primary completing comleting for child (Spanish Version)
Brigham & Women's Hospital
Dana-Farber Cancer Institute
University of Michigan
CSER Phase 1 Results Report Template
Baylor College of Medicine
Brigham & Women's Hospital
Children's Hospital of Philadelphia
ClinSeq
Dana-Farber Cancer Institute
HudsonAlpha
Kaiser Permanente
- Negative Carrier Status Report Template
- Positive Carrier Status Report Template
- Negative Whole Genome Sequencing Incidental Findings Template
University of Michigan
University of North Carolina
University of Washington
- Report Template for Positive Incidental Finding result
- Report Template for Negative Diagnosis Result
- Report Template for Positive Diagnosis Result
CSER Phase 1 Description of Variant Analysis Pipeline
Baylor College of Medicine
Brigham & Women's Hospital
University of North Carolina
- NCGenes Medical Workflow Engine Description
- NCGenes Variant Database Description
- NCGenes MapSeq Sequence Analysis Workflow Description
CSER Phase 1 Framework for Primary and Secondary Results
Baylor College of Medicine
HudsonAlpha
Kaiser Permanente
- List of Genes/Conditions reported for Carrier Status
- List of Genes/Conditions reported for Incidental Findings