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 Consent Forms
CHARM
KidsCanSeq
- KidsCanSeq Age of Majority Consent Form - Germline and Tumor
- KidsCanSeq Age of Majority Consent Form - Germline ONLY
- KidsCanSeq Parent Consent Form
- KidsCanSeq Patient Consent Form - Germline and Tumor
- KidsCanSeq Patient Consent Form - Germline ONLY
- KidsCanSeq Physician Consent
- KidsCanSeq Spanish Age of Majority Germline and Tumor Consent Form
- KidsCanSeq Spanish Age of Majority Germline ONLY Consent Form
- KidsCanSeq Spanish Parent Consent Form
- KidsCanSeq Spanish Patient Consent Form - Germline and Tumor
- KidsCanSeq Spanish Patient Consent Form - Germline ONLY
NCGENES 2
- Assent to Participate in a Research Study (Child Subjects ages 15-17)
- Assent to Participate in a Research Study (Child Subjects ages 7-14)
- Assent to Research Genomic Sequencing (Child Subjects ages 15-17)
- Assent to Research Genomic Sequencing (Child Subjects ages 7-14)
- Consent to Participate in a Research Study
- Consent to Research Genomic Sequencing
NYCKidSeq
- NYCKidSeq Assent
- NYCKidSeq Cognitively Intact 18-21 Year Old ICF
- NYCKidSeq Parent of 0-17 Year Old Child ICF
- NYCKidSeq Parent of Cognitively Incapacitated 18-21 Child ICF
- NYCKidSeq Parent of Cognitively Intact 18-21 Year Old ICF
- NYCKidSeq Parental Baseline Survey ICF
- NYCKidSeq Reconsent of Cognitively Intact Minor Turned 18 Years ICF
- SPANISH NYCKidSeq Assent
- SPANISH NYCKidSeq Cognitively Intact 18-21 Year Old ICF
- SPANISH NYCKidSeq Parent of 0-17 Year Old Child ICF
- SPANISH NYCKidSeq Parent of Cognitively Incapacitated 18-21 Child ICF
- SPANISH NYCKidSeq Parent of Cognitively Intact 18-21 Child ICF
- SPANISH NYCKidSeq Reconsent of Cognitively Intact Minor Turned 18 Years ICF
- SPANISH Parental Baseline Survey ICF
- SPANISH TeleKidSeq Assent
- SPANISH TeleKidSeq Cognitively Intact 18-21 Year Old ICF
- SPANISH TeleKidSeq Parent of 0-17 Year Old Child ICF
- SPANISH TeleKidSeq Parent of Cognitively Incapacitated 18-21 Child ICF
- SPANISH TeleKidSeq Parent of Cognitively Intact 18-21 Child ICF
- SPANISH TeleKidSeq Parental Baseline Survey ICF
- SPANISH TeleKidSeq Reconsent of Cognitively Intact Minor Turned 18 Years ICF
- TeleKidSeq Assent
- TeleKidSeq Cognitively Intact 18-21 Year Old ICF
- TeleKidSeq Parent of 0-17 Year Old Child ICF
- TeleKidSeq Parent of Cognitively Incapacitated 18-21 Year Old ICF
- TeleKidSeq Parent of Cognitively Intact 18-21 Year Old ICF
- TeleKidSeq Parental Baseline Survey ICF
- TeleKidSeq Reconsent of Cognitively Intact Minor Turned 18 Years ICF
P3EGS
SouthSeq
- Consent Form - CHNOLA
- Consent Form - CHNOLA (Spanish)
- Consent Form - UAB
- Consent Form - UAB (Spanish)
- Consent Form - UMMC
- Consent Form - UMMC (Spanish)
- Consent Form - University of Lousiville
- Consent Form - University of Lousiville (Spanish)
- Consent Form - Woman's Hospital, Baton Rouge, Louisiana
- Consent Form - Woman's Hospital, Baton Rouge, Louisiana (Spanish)
CSER Phase 2 Protocols and Research Materials
CHARM
KidsCanSeq
- Age of Majority Lost to Follow Up Certified Letter
- AOM Lost to Follow Up Certified Letter - Spanish
- KidsCanSeq Lost to Follow-up Certified Letter (English)
- KidsCanSeq Lost to Follow-up Certified Letter (Spanish)
- KidsCanSeq Study Protocol
NCGENES 2
NYCKidSeq
- NYCKidSeq Study Protocol
- TeleKidSeq Study Protocol
- Genomic Understanding, Information, and Awareness (GUIA)
- GenomeDiver
SouthSeq
CSER Phase 2 Surveys
KidsCanSeq
NYCKidSeq
- NYCKidSeq Baseline Survey
- NYCKidSeq Baseline Survey - Spanish
- NYCKidSeq Return of Results Follow-up Survey #1
- NYCKidSeq Return of Results Follow-up Survey #1 - Spanish
- NYCKidSeq Provider Return of Results Follow-up Survey #1
- NYCKidSeq Return of Results Follow-up Survey #2
- NYCKidSeq Return of Results Follow-up Survey #2 - Spanish
- TeleKidSeq Baseline Survey
- TeleKidSeq Baseline Survey - Spanish
- TeleKidSeq Return of Results Follow-up Survey #1
- TeleKidSeq Return of Results Follow-up Survey #1 - Spanish
- TeleKidSeq Return of Results Follow-up Survey #2
- TeleKidSeq Return of Results Follow-up Survey #2 - Spanish
CSER Phase 2 Educational Materials
CHARM
KidsCanSeq
- Genetics Glossary
- Genetics Glossary (Spanish)
- Germline and Tumor Results Explanation Card
- Germline and Tumor Results Explanation Card (Spanish)
- Germline Results Explanation Card
- Germline Results Explanation Card (Spanish)
- VUS Education Document
- VUS Education Document (Spanish)
- QR Codes to Videos (English)
- QR Codes to Videos (Spanish)
NCGENES 2
- NCGENES 2 Study Brochure - Recruitment (2020-06-15) (English)
- NCGENES 2 Study Brochure - Recruitment (2020-06-15) (Spanish)
- Resources for Distressed Participants (English)
- Resources for Distressed Participants (Spanish)
CSER Phase 2 Results Templates
CHARM
KidsCanSeq
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