| Category | Element | Not implemented | Partially Implemented | Implemented | Advanced implementation | Documentation | | -------------------------- | ------------------------------------------------------------ | ----------------------------------------------------------------- | ------------------------------------------------------------------------------ | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------- | | 1.1 Longitudinal Follow-up | Regular follow-up | Last follow-up more than one year ago | Annual follow-up | Regular follow-ups scheduled and completed >= annually | Continuous follow-up through real time reporting of events | Data monitoring reports | | | Loss to follow-up | Unable to determine or more than 10% loss per annum | Less than 10% loss to follow-up per annum | Less than 5% loss to follow-up per annum | Less than 1% loss-to-follow-up per annum | Data monitoring reports and annual report to ethics national bodies | | | Contact rate | Unable to determine or less than 60% contact rate per annum | More than 60% contact rate per annum | More than 80% contact rate per annum | More than 95% contact rate per annum | | | 1.2 Operational Management | Surveillance Schedule | No explicit surveillance schedule | Some form of systematic process covering schedule for each surveillance round | Weekly program of exactly which subset of the cohort should be contacted | Data collection performance management program linked to weekly schedule | | | | Standard operating procedures | No SOPs | Basic. SOPs covering some but not all aspects of cohort management | Up to date SOPs covering all aspects of cohort management | SOPs and operational manuals in place and up to date | SOPs, operations manuals | | 1.3 Quality assurance | Operational Audit | No quality control or assurance programmes | Some quality control or assurance, but not systematic or comprehensive | Comprehensive quality assurance programmes based on internationally accepted standards | Received internationally recognised accreditation of processes with external assessment | Policy, SOP, report, certification | | 1.4 Data collection | Tools: method | Paper and pen | Electronic collection<br>or<br>Paper + double entry | Using recognized software with QC checks | Real-time monitoring of data collection through web-based tools | | | | Tools: instrument validation | None or only some available | Available in English (with translations) | Pretested and validated questionnaires | Documented pretested and validated questionnaires available with training guides | | | | Tools: data validation/checks | None | Ad hoc checks by data manager. No feedback to field team | Ad hoc checks on the data with feedback to field team to resolve | Daily automated data validity & integrity checks with immediate feedback to data collection teams | | | | Geocoding | None | GPS mapping of dwellings done in the past but not updated within the last year | GPS mapping kept up to date, with newly constructed or destroyed dwellings updated on a regular basis | Health care and other facilities of interest mapped as well | | | | Meteorological measurement | None | Surface weather station in proximity of cohort location | One or more automated weather stations within the geographic boundaries of the cohort, measuring at least temperature, humidity, wind speed and direction, precipitation and solar radiation. | A climate reference station within the geographic boundaries of the cohort | | | | Frontline staff skills | No documented training | Documented pre-survey training, but no training continuity | Formalised training events and periodic refresher training with skills assessment and development | Formalised training events and periodic refresher training with skills assessment and development linked to ongoing performance appraisal | | | 1.5 Data Processing | Programming | Ad hoc or legacy software with no maintenance plan or source code | Incomplete set of programs for data processing | Complete and maintained data collection software environment | Capacity to develop or part of an open source development community | | | | Archival data storage | On researcher/PI computer | Institutional server | Institutional server with off-site backup or cloud storage | Institutional or cloud server with business continuity fail-over | | | | Data extraction, transformation, loading and analysis (ETLA) | Not available | Mainstream data analysis tools available | Standardisation on a limited set of tools with institutional user training and usage guidelines | Automated routine analysis for regular indicators needed in the study | | | 1.6 Sample collection | Biosample collection frequency | No biosample collection | Ad hoc collection (when needed by others) | Frequency of sample collection established | Frequency established and complied with for >5 years | | | | Sample collection completeness | Not applicable | Ad hoc collection on part of cohort | 40-60% of cohort target group sampled | >60% of cohort target group sampled | | | | Sample storage | Not applicable | Some samples stored and labelled, no systematic storage | Samples stored and labelled and mostly available in computer database | Complete LIMS system for samples with knowledge of missing samples and use of samples for different analyses | | | | Relevance and sufficiency | No assessment of relevance | Relevance and sufficiency of the samples reviewed more than five years ago | Regular review of relevance and sufficiency of samples collected | Sample relevancy and sufficiency reviewed with annual reports to oversight board | | | 1.7 Sustainable funding | Available funding | No current funding for cohort operations | Funding for the next year of cohort operations | Funding for three years or more for cohort operations | Funding for at least 5 years of cohort operations and/or a sustainability business plan based on user fees for nested studies | | | | Sustainability | Ad hoc project-based funding | Cohort-specific project funding | Institutional core funding for cohort maintenance | Long-term funding as a national or regional research infra-structure | |