Streamlined Data Collection Emmanuelle Denis CREDO Workshop 1 UVRI, Entebbe, Uganda 9 March, 2017

Data: management, harmonisation and sharing module Intended Learning Objectives At the end of the module participants will be able to: Explain the important role of data harmonisation and sharing in outbreak research Describe the elements of a data management plan Identify outbreak research platforms for sharing and developing protocols and data capture tools There is a module of CREDO that covers data management, harmonisation and sharing of clinical research data.

Streamlined data collection Intended Learning Objectives To understand the benefits of streamlined data collection To be able to plan efficient data collection for a study This short talk will focus on ways to streamline data collection for a study and reduce the gathering of extraneous or unnecessary data

Keep it simple For every question, measurement or test ask: What am I collecting this information for? Avoid collecting extraneous (‘just in case’) data - remember that all data collected will need to be entered and cleaned Collect only the data variables that are required by the protocol and needed for your database The ultimate goal is to ensure that the information generated from the data can answer the research question

Plan ahead Case report form (CRF) development should be done concurrently with protocol development Allow plenty of time for revisions and for validation and testing if you are going to use an electronic CRF

Don’t reinvent the wheel If you have run other clinical research studies in your institute you can probably adapt their CRFs – particularly for ‘standard’ modules like demographics or adverse events ISARIC has freely available Severe Acute Respiratory Infection and Viral Haemorrhagic Fever Data Tools https://isaric.tghn.org/protocols/

Reasons for data collection Why? When? Who? Eligibility Screening Everyone Identify subgroups Randomization Safety Every follow-up Everyone (not just those on treatment) Compliance measures Particular times during follow-up Random sample or everyone? Outcomes Other outcome measures Final follow-up Random sample or everyone So the important questions to ask are: why am I collecting this data, when do I need to collect it? and on whom do I need to collect it? I borrowed this slide from a colleague who works in Oxford’s Clinical Trial Service Unit (CTSU). CTSU specialises in ‘mega-trials’ of cancer and cardiovascular disease that enrol thousands of patients so the last question is of particular importance to them since some questions may be answered by collecting data on only a random sample of participants . In a smaller trial of an infectious disease you will probably need to collect all data on all participants Table courtesy of Dr Marion Mafham, Senior Clinical Research Fellow, CTSU, University of Oxford

Recommendations for CRF design Necessary Data Only Design the CRF along with protocol to assure collection of only these data the protocol specifies. CRFs should avoid collecting redundant data and should instead focus on collecting only the data needed to answer the protocol questions and to provide adequate safety and efficacy data Minimise the collection of data as ‘free text’

Recommendations for CRF design Keep questions, prompts and instructions clear and concise. Design the CRF to follow the data flow from the perspective of the person completing it, taking into account the flow of study procedures

Recommendations for CRF design Avoid recording calculated data Example: Body mass index –> record weight and height X 

Recommendations for CRF design Avoid recording calculated data Example: Dates Time Point Date Calculation Baseline 16-Oct-2017 =baseline Day 1 17-Oct-2017 =baseline+1 Day 3 19-Oct-2017 =baseline+3 Day 7 23-Oct-2017 =baseline+7 Day 14 30-Oct-2017 =baseline+14

Recommendations for CRF design Avoid redundant data points within the CRF whenever possible. -> i.e. don’t collect the same information twice!

Recommendations for CRF design Document the process for CRF design, development, approval and version control. Make the CRF available at the clinical site prior to enrolment of a subject. Document training of clinical site personnel on the protocol, CRF completion instructions and data submission procedures prior to enrolment of a subject.