Data Management Sop - Draft - SHARP

Data management Standard operation procedure
Standard Operating Procedure (SOP)
Title: SOP on Data Management
SOP #: 102
Version:
Effective date:
Signature PI:
Signature site PI:
1. PURPOSE
This document describes the process by which SHARP staff in the United Kingdom, Ethiopia and Ghana
will ensure that information held about participants involved in the research process is managed in an
ethical and legally compliant manner.
In particular, it defines the processes that should be followed for:

- Storing research data
- backup data
- secure data
- Sharing data
2. SCOPE
This SOP relates to the storage, backup data, secure data, and sharing of data. The scope of this
procedure is for research data collected by LSHTM staff and partners’ staff conducting research in the
United Kingdom, Ethiopia.
3. INTENDED USERS
The intended users of this SOP are the SHARP data managers and/or project coordinator, Principal
Investigators, Co-Principal Investigators.
4. RESPONSIBILITIES
All staff and students at LSHTM are responsible for ensuring they maintain the confidentiality of
research data. It is the responsibility of the project lead to ensure appropriate oversight of data security
for a research project. Where the research is conducted with other institutions and/or external
researchers, LSHTM researchers are responsible for the management of research data that are under
their own control.
If all researchers associated with the research data have left LSHTM, responsibility for the research data
will fall to the Head of Department in the first instance.
The responsibility for ensuring new staff members are aware of this SOP resides with their immediate
line manager.
Resources
To successfully carry out this plan, the following resources are required
1. RedCap server
2. Redcap mobile app
3. Tablet
4. Audio record
5. Hard copy of data collection tool/instrument
6. Change Request Log
7. Data Dictionary
8. Secure Cabinets / Archive room
Carefully consider any resources needed to deliver the plan, e.g. software, hardware, technical
expertise, etc. Where dedicated resources are needed, these should be outlined and justified
5. Procedure
Electronic data management system
Data from the tablets will be transferred at the end of every day to our data core facilities at AHRI. Data
on CRF will be entered into a computerized database REDcap by a data entry clerk and will be double-
entered to verify accuracy and quality. Databases will be compared and any discrepancies evaluated by
a third person. All data will be recorded on case report form and linked to the individual study
participant’s collections using a unique identifier. Data will be transferred to the project specific Cl
cohort study on REDcap server.
STORAGE, SECURITY, AND BACKUP

 Data will be collected using Redcap mobile app version 5.19.7 on tablet
 Data collected is synced every day to the Redcap server
 Data will be checked every completeness, validation and redundancy.
 All the data is backed up 3 times daily and replicated to a secure secondary offsite data center
nightly.
 A full disaster recovery plan is in place that allows recovery from any hardware failure or data
corruption or total loss of any equipment that holds data.
 Paper records will be kept to a minimum. However, where paper records are unavoidable, they
will be locked in secure, fireproof cabinets in secure locations.
 Access will only be granted by research leads. Once double entered, validated datasets will also
be uploaded to the REDcap server every day.
 REDcap allows for flexible data storage and access, which will use permissions to control access
to relevant data when and where appropriate.
 The file structure will be divided into workstreams and appropriate permissions will be applied,
ensuring that only those who need to see the data are able to do so. Data files will only be
accessible to authorized study personnel. We will use a consistent naming convention including
all relevant info (e.g., date of export, version number).
Data sharing
 Datasets will be made available either through the above-mentioned repositories or directly
from the investigators on request. All data requests must be approved by the project PIs and a
Data Transfer Agreement (DTA) must be signed by all stakeholders.
 All DATAs will be managed by the Programme Manager. An access/usage log will also be
maintained by the Project Manager by the specific repository. This will detail who was given
access to what data, how data is accessed, when approval was granted, by whom and why.
Restrictions to sharing
 No data will be shared until study findings are published. The investigators will have exclusive
access to the data for a period of 5 years. This will be extended for 2 years to protect any Ph.D.
students who may be working on the project.
 The project will adhere to AHRI’s Policy on Research Data Sharing. The only limits to data sharing
will be to safeguard research participants’ confidentiality.

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Data Management Sop - Draft - SHARP

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Data management Standard operation procedure

Standard Operating Procedure (SOP)

Title: SOP on Data Management

Signature site PI:

In particular, it defines the processes that should be followed for:

Electronic data management system

STORAGE, SECURITY, AND BACKUP

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