Forms - isaric4c/wiki GitHub Wiki
| Form Name | Form Label | Description | Hospital Discharge (redcap_event_name: hospital_discharge_arm_1) | 6 Weeks (redcap_event_name: 6_weeks_arm_1) | 3 Months (1st Research Visit) (redcap_event_name: 3_months_1st_resea_arm_1) | Add. Planned Clincal Visits (redcap_event_name: add_planned_clinic_arm_1) | 12 Months (2nd Research Visit) (redcap_event_name: 12_months_rese_arm_1) | Unscheduled (redcap_event_name: unscheduled_arm_1) |
|---|---|---|---|---|---|---|---|---|
| phosp_id | PHOSP ID | Participant PHOSP ID and tier allocation | Y | N | N | N | N | N |
| econsent_tier_1 | eConsent Tier 1 | Tier 1 eConsent form | Y | N | N | N | N | N |
| econsent | eConsent | Full eConsent form | Y | N | N | N | N | N |
| registration_and_informed_consent | Registration and Informed Consent | Other methods of consent - Face-to-face, postal, telephone, consultee declaration | Y - Repeatable (One instance for each consent form completed) | N | N | N | N | N |
| split_tier_recruitment_informed_consent_2 | Split Tier Informed Consent | Consent forms for split tier recruitment procedures | Y - Repeatable (One instance for each consent form completed) | N | N | N | N | N |
| eligibility_checklist | Eligibility Checklist | Eligibility checklist to participate in the PHOSP study | Y | N | N | N | N | N |
| crf1a_baseline_clinical_data_part_1_q1_q8 | CRF1A Part 1 | Baseline clinical data: Sex at birth; pregnancy (females only); onset and admission; vital signs at hospital admission; admission signs and symptoms; pre-admission medication | Y | N | N | N | N | N |
| crf1a_baseline_clinical_data_part_2_q9 | CRF1A Part 2 | Baseline clinical data: Co-morbidities | Y | N | N | N | N | N |
| crf1a_baseline_clinical_data_part_3_q10_q15 | CRF1A Part 3 | Baseline clinical data: Respiratory support, treatments during hospitalisation, additional diagnoses/complications, clinical laboratory results during admission, acute COVID trial enrolment | Y | N | N | N | N | N |
| crf1b_baseline_demographic_data | CRF1B | Baseline demographic data: Ethnicity, education, annual household income, disability, living arrangements, gender identity, occupation | Y | N | N | N | N | N |
| crf2a_followup_telephone_triage | CRF2A | 6-week post-discharge telephone triage (where completed). | N | Y | N | N | N | N |
| crf2b_followup_triage_review | CRF2B | 6-week post-discharge triage review (where completed) - To be used for those offered a chest x-ray after telephone triage | N | Y | N | N | N | N |
| crf3a_clinical_data_section | CRF3A | COVID-related clinical follow-up/consultation which falls within time window for research visit 1 (2-7 months, +/-2 weeks) or research visit 2 (10-14 months): Resting observatons, chest-xray results, ECG results, additional investigations/procedures, questionnaires, blood tests, PFTs, walk test | N | N | Y | N | Y | N |
| crf3b_research_data_section | CRF3B | Research visit 1 (2-7 months, +/-2 weeks) and research visit 2 (10-14 months) CRF for Tier 2 participants: Core Tier 2 research procedures | N | N | Y | N | Y | N |
| crf3c_additional_research_procedures | CRF3C | Research visit 1 (2-7 months, +/-2 weeks) and research visit 2 (10-14 months) CRFfor Tier 2 participants: Additional research procedures, Tier 3 study involvement, GenOMICC co-enrolment | N | N | Y | N | Y | N |
| crf4a_clinical_data_section | CRF4A | COVID-related clinical follow-up/consultation which falls outside of the time window for research visit 1 (2-7 months, +/-2 weeks) or research visit 2 (10-14 months): Resting observatons, chest-xray results, ECG results, additional investigations/procedures, questionnaires, PFTs, walk test | N | N | N | Y - Repeatable (One instance for each clinical follow-up available) | N | N |
| crf4b_research_data_section | CRF4B | Any additional research blood sampling that falls outside of the research window (between 7 and 10 months post-discharge) | N | N | N | Y - Repeatable (One instance for each clinical follow-up available) | N | N |
| crf_emergency_visit | Emergency Visit CRF | Emergency visits: Presenting symptoms, hospital visit details, investigations/procedures, admission blood tests. | N | N | N | N | N | Y - Repeatable (One instance for each emergency visit attended) |
| adverse_events_log | Adverse Events Log | Adverse Events which have occurred as a result of taking part in a research procedure | N | N | N | N | N | Y - Repeatable (One instance for each Adverse Event) |
| withdrawals | Withdrawal form | Participant withdrawal from PHOSP study - withdrawal form received directly from participant | N | N | N | N | N | Y |
| early_termination_crf | Early termination CRF | Participant withdrawal from PHOSP study as notified by participant via alternative methods than withdrawal form e.g. telephone call | N | N | N | N | N | Y |
| crf_tier_2_consent_withdrawal | Tier 2 withdrawal CRF | Participant withdrawing from Tier 2 research activity to Tier 1 participation in the PHOSP study | N | N | N | N | N | Y |
| repeatable_medications_log | Medications log | Prescribed medication from point of discharge to 12 months post-discharge: Medication name, class, start/end date, dosage, frequency, route, indication/reason | Y - Repeatable (One instance for each prescribed medication) | Y - Repeatable (One instance for each prescribed medication) | Y - Repeatable (One instance for each prescribed medication) | Y - Repeatable (One instance for each prescribed medication) | Y - Repeatable (One instance for each prescribed medication) | Y - Repeatable (One instance for each prescribed medication) |
| activity_monitor_completion_form | Activity monitor completion log | Tier 2 participants only: Notification that activity monitor has been sent to participant and returned. | N | N | Y | N | Y | N |
| repeatable_mental_health_assessment | Mental health assessment | Mental health assessment section completed as part of CRF2A (6-weeks post-discharge telephone triage) | N | Y | N | N | N | N |
| repeatable_nutrition | Nutrition | Nutrition section completed as part of CRF2A (6-weeks post-discharge telephone triage) | N | Y | N | N | N | N |
| repeatable_social_history | Social history | Social history questions completed as part of CRF3B or pre-COVID Patient Symptom Questionnaire | N | N | Y | N | Y | N |
| repeatable_eq5d5l | EQ-5D-5L | Pre-COVID EQ-5D-5L available at: 1. 6-weeks telephone triage where available (CRF2) 2. Tier 2 research visit (CRF3B prior to version 2.0 - only completed if CRF2 not completed) 3. Pre-COVID Patient Symptom Questionnaire - Completed at Tier 2 research visit (Introduced from Substantial Amendment 5; 19-Feb-21) Current EQ-5D-5L available at: 1. 6-weeks telephone triage where available (CRF2) 2. Patient Questionnaire Booklet - Completed at Tier 2 research visit 3. Completed at COVID-related clinical follow-up where available (CRF3A/CRF4A) |
N | Y | Y | Y - Repeatable (One instance for each clinical follow-up available) | Y | N |
| repeatable_general_anxiety_disorder_7_questionnair | General Anxiety Disorder-7 (GAD-7) | Completed at Tier 2 research visit 1 (2-7 months, +/-2 weeks) and research visit 2 (10-14 months) or may be completed as part of COVID-related clinical follow-up where available | N | N | Y | Y - Repeatable (One instance for each clinical follow-up available) | Y | N |
| repeatable_patient_health_questionnaire9_phq9 | Patient Health Questionnaire-9 (PHQ-9) | Completed at Tier 2 research visit 1 (2-7 months, +/-2 weeks) and research visit 2 (10-14 months) or may be completed as part of COVID-related clinical follow-up where available | N | N | Y | Y - Repeatable (One instance for each clinical follow-up available) | Y | N |
| repeatable_mrc_dyspnoea_scale | MRC Dyspnoea scale | Pre-COVID MRC Dyspnoea available at: 1. 6-weeks telephone triage where available (part of CRF2) 2. Tier 2 research visit (CRF3B prior to version 2.0 - only completed if CRF2 not completed) 3. Pre-COVID Patient Symptom Questionnaire - Completed at Tier 2 research visit (Introduced from Substantial Amendment 5; 19-Feb-21) Current MRC Dyspnoea available at: 1. 6-weeks telephone triage where available (part of CRF2) 2. Patient Questionnaire Booklet - Completed at Tier 2 research visit 3. Completed at COVID-related clinical follow-up where available (CRF3A/CRF4A) |
N | Y | Y | Y - Repeatable (One instance for each clinical follow-up available) | Y | N |
| repeatable_sarcf_questionnaire | SARC-F | Completed at Tier 2 research visit 1 (2-7 months, +/-2 weeks) and research visit 2 (10-14 months) or may be completed as part of COVID-related clinical follow-up where available | N | Y | Y | Y - Repeatable (One instance for each clinical follow-up available) | Y | N |
| repeatable_general_practice_physical_activity_ques | General Practice Physical Activity Questionnaire (GPPAQ) | Completed at Tier 2 research visit 1 (2-7 months, +/-2 weeks) and research visit 2 (10-14 months) or may be completed as part of COVID-related clinical follow-up where available | N | Y | Y | Y - Repeatable (One instance for each clinical follow-up available) | Y | N |
| repeatable_dyspnoea12 | Dypnoea-12 | Completed at Tier 2 research visit 1 (2-7 months, +/-2 weeks) and research visit 2 (10-14 months) or may be completed as part of COVID-related clinical follow-up where available | N | N | Y | Y - Repeatable (One instance for each clinical follow-up available) | Y | N |
| repeatable_facit_fatigue_scale_v4 | FACIT Fatigue Scale V4 | Completed at Tier 2 research visit 1 (2-7 months, +/-2 weeks) and research visit 2 (10-14 months) or may be completed as part of COVID-related clinical follow-up where available | N | N | Y | Y - Repeatable (One instance for each clinical follow-up available) | Y | N |
| repeatable_ptsd_checklist_for_dsm5_pcl5 | PSTD Checklist for DSM-5 (PCL-5) | Completed at Tier 2 research visit 1 (2-7 months, +/-2 weeks) and research visit 2 (10-14 months) or may be completed as part of COVID-related clinical follow-up where available | N | N | Y | Y - Repeatable (One instance for each clinical follow-up available) | Y | N |
| repeatable_brief_pain_inventory_short_form | Brief Pain Inventory (BPI) | Completed at Tier 2 research visit 1 (2-7 months, +/-2 weeks) and research visit 2 (10-14 months) or may be completed as part of COVID-related clinical follow-up where available | N | N | Y | Y - Repeatable (One instance for each clinical follow-up available) | Y | N |
| repeatable_nottingham_extended_adl_scale | Nottingham Extended Activities of Daily Living scale (NEADL) | Completed at Tier 2 research visit 1 (2-7 months, +/-2 weeks) and research visit 2 (10-14 months) or may be completed as part of COVID-related clinical follow-up where available | N | N | Y | Y - Repeatable (One instance for each clinical follow-up available) | Y | N |
| repeatable_montreal_cognitive_assessment_moca | Montreal Cognitive Assessment (MoCA) | Completed at Tier 2 research visit 1 (2-7 months, +/-2 weeks) and research visit 2 (10-14 months) or may be completed as part of COVID-related clinical follow-up where available | N | N | Y | Y - Repeatable (One instance for each clinical follow-up available) | Y | N |
| repeatable_rockwood_clinical_frailty_scale | Rockwood Clinical Frailty Scale | Collected at hospital admission and 6-week telephone triage where available; Completed at Tier 2 research visit 1 (2-7 months, +/-2 weeks) and research visit 2 (10-14 months) or may be completed as part of COVID-related clinical follow-up where available | Y | Y | Y | Y - Repeatable (One instance for each clinical follow-up available) | Y | N |
| repeatable_pittsburgh_sleep_quality_index_psqi | Pittsburgh Sleep Quality Index (PSQI) | Tier 2 participants only: Additional questionnaire which may be completed as part of research visit 1 (2-7 months, +/-2 weeks) and research visit 2 (10-14 months) | N | N | Y | N | Y | N |
| repeatable_morningnesseveningness_questionnaire_me | Morningness-Eveningness Questionnaire (MEQ) | Tier 2 participants only: Additional questionnaire which may be completed as part of research visit 1 (2-7 months, +/-2 weeks) and research visit 2 (10-14 months) | N | N | Y | N | Y | N |
| repeatable_leicester_cough_questionnaire | Leicester Cough Questionnaire (LCQ) | Tier 2 participants only: Additional questionnaire which may be completed as part of research visit 1 (2-7 months, +/-2 weeks) and research visit 2 (10-14 months) | N | N | Y | N | Y | N |
| repeatable_pulmonary_functional_tests | Pulmonary Function Tests (PFTs) | Completed at Tier 2 research visit 1 (2-7 months, +/-2 weeks) and research visit 2 (10-14 months) or may be completed as part of COVID-related clinical follow-up where available: FEV1, FVC, FEV1/FVC, TLCO, KCO, MIP, MEP | N | N | Y - Repeatable (One instance for PFTs recorded at CRF3A and CRF3B) | Y - Repeatable (One instance for each clinical follow-up available) | Y - Repeatable (One instance for PFTs recorded at CRF3A and CRF3B) | N |
| repeatable_walk_test_6_min_iswt_15_level | 6-Minute walk test / Incremental shuttle walk test | Completed at Tier 2 research visit 1 (2-7 months, +/-2 weeks) and research visit 2 (10-14 months) or may be completed as part of COVID-related clinical follow-up where available | N | N | Y - Repeatable (CRF3A, and up to two walk tests conducted for CRF3B) | Y - Repeatable (One instance for each clinical follow-up available) | Y - Repeatable (CRF3A, and up to two walk tests conducted for CRF3B) | N |
| repeatable_tier_2_core_tests_checklist | Tier 2 core tests checklist | Tier 2 participants only: Checklist of which routine blood test, fasting sample tests, and urine sample tests were requested as part of research visit 1 (2-7 months, +/-2 weeks) and research visit 2 (10-14 months) | N | N | Y | N | Y | N |
| repeatable_tier_2_biological_research_samples_chec | Tier 2 biological research samples checklist | Tier 2 participants only: Checklist of which biological research samples were collected as part of research visit 1 (2-7 months, +/-2 weeks) and research visit 2 (10-14 months) | N | N | Y | Y - Repeatable (One instance for each clinical follow-up available) | Y | N |
| repeatable_tier_2_core_sample_notification_form_bl | Tier 2 sample notiication form - Blood | Tier 2 participants only: Notification form for blood sample taken at research visit 1 (2-7 months, +/-2 weeks) and research visit 2 (10-14 months) | N | N | Y | Y - Repeatable (One instance for each clinical follow-up available) | Y | N |
| repeatable_tier_2_core_sample_notification_form_or | Tier 2 sample notification form - Oral wash | Tier 2 participants only: Notification form for oral wash sample taken at research visit 1 (2-7 months, +/-2 weeks) and research visit 2 (10-14 months) | N | N | Y | N | Y | N |
| repeatable_tier_2_core_sample_notification_form_sp | Tier 2 sample notification form - Sputum | Tier 2 participants only: Notification form for sputum sample taken at research visit 1 (2-7 months, +/-2 weeks) and research visit 2 (10-14 months) | N | N | Y | N | Y | N |
| repeatable_tier_2_core_sample_notification_form_ur | Tier 2 sample notification form - Urine | Tier 2 participants only: Notification form for urine sample taken at research visit 1 (2-7 months, +/-2 weeks) and research visit 2 (10-14 months) | N | N | Y | N | Y | N |
| repeatable_qrisk3 | QRISK3 | Tier 2 participants only: QRISK3 algorithm completed at research visit 1 (2-7 months, +/-2 weeks) and research visit 2 (10-14 months) | N | N | Y | N | Y | N |
| repeatable_body_composition_measurements_bia | Body composition measurements - BIA | Tier 2 participants only: BIA assessment completed at research visit 1 (2-7 months, +/-2 weeks) and research visit 2 (10-14 months) | N | N | Y | N | Y | N |
| repeatable_body_composition_measurements_dxa | Body composition measurements - DXA | Tier 2 participants only: DXA assessment completed at research visit 1 (2-7 months, +/-2 weeks) and research visit 2 (10-14 months) | N | N | Y | N | Y | N |
| repeatable_muscle_strength | Muscle strength | Tier 2 participants only: Handgrip and quadricep strength assessment completed at research visit 1 (2-7 months, +/-2 weeks) and research visit 2 (10-14 months) | N | N | Y | N | Y | N |
| repeatable_short_physical_performance_battery_sppb | Short Physical Performance Battery (SPPB) | Tier 2 participants only: SPPB completed at research visit 1 (2-7 months, +/-2 weeks) and research visit 2 (10-14 months) | N | N | Y | N | Y | N |
| precovid_patient_symptom_questionnaire | Pre-COVID Patient Symptom Questionnaire (Pre-PSQ) | Completed at Tier 2 research visit 1 (2-7 months, +/-2 weeks) and research visit 2 (10-14 months) - Introduced from Substantial Amendment 5 (19-Feb-21) | N | N | Y | N | Y | N |
| repeatable_symptoms_assessment | Patient Symptom Questionnaire (PSQ) | Used as part of 6-week telephone triage (CRF2); completed at Tier 2 research visit 1 (2-7 months, +/-2 weeks) and research visit 2 (10-14 months) | N | Y | Y | N | Y | N |
| repeatable_laboratory_results_collection_log_routi | Laboratory log form - Routine blood tests | Tier 2 core tests or routine blood tests collected as part of COVID-related clinical follow-up where available: Full blood count; U&Es; LFTs; CRP; bone profile; lipid profile; cardiac profile; haematology profile; diabetes profile | N | N | Y - Repeatable (One instance for each date of test results) | Y - Repeatable (One instance for each date of test results) | Y - Repeatable (One instance for each date of test results) | Y - Repeatable (One instance for each date of test results) |
| repeatable_laboratory_results_collection_log_urine | Laboratory log form - Urine | Tier 2 core tests or urine profile collected as part of COVID-related clinical follow-up: albumin:creatinine ratio (ACR); protein:creatinine ratio (PCR); urinalysis | N | N | Y - Repeatable (One instance for each date of test results) | Y - Repeatable (One instance for each date of test results) | Y - Repeatable (One instance for each date of test results) | Y - Repeatable (One instance for each date of test results) |
| repeatable_laboratory_results_collection_log_immun | Laboratory log form - Immunological profile | Immunological profile collected as part of COVID-related clinical follow-up where available: auto-immune screen; immunological screen; bloodborne viruses screen | N | N | Y - Repeatable (One instance for each date of test results) | Y - Repeatable (One instance for each date of test results) | Y - Repeatable (One instance for each date of test results) | Y - Repeatable (One instance for each date of test results) |
| repeatable_laboratory_results_collection_log_addit | Laboratory log form - Additional blood tests | Additional blood tests collected as part of COVID-related clinical follow-up where available: haematological profile; thyroid function tests; SARS-CoV-2 serology | N | N | Y - Repeatable (One instance for each date of test results) | Y - Repeatable (One instance for each date of test results) | Y - Repeatable (One instance for each date of test results) | Y - Repeatable (One instance for each date of test results) |
| repeatable_sarscov2_swab_pcr_test_result | SARS-Cov-2 PCR Swab test results | PCR Swab test results for each test conducted during COVID-19 index admission | Y - Repeatable (One instance for each PCR swab taken during hospital admission) | N | N | N | N | N |