18.104.22.168 Traceability of data and any person having impact on data
A. Background & Definitions
This item refers to one of the Core Requirements (Core Requirement 8 - "Reported research outcomes must be traceable to experimental data") and is, therefore, considered as essential.
Traceability: The ability to find the source of data (primary and secondary) and any person having relevant impact on data sets that are presented in a report or other presentation.
Experimental Record: An entry in an (electronic) laboratory notebook for an experiment recording all data and pertinent details of an experiment such that a peer could repeat the experiment.
The user must ensure the traceability and integrity of the data so that the reported results can be reconstructed.
B. Guidance & Expectations
- Each experimental record should contain or cross-reference/link to:
- Names of all individuals involved in generating the content of the experimental record.
- Specific research plan, objective, or hypothesis to be addressed by the experiment.
- All protocols, standard operating procedures, test methods, statistical tools (and/or software used for data analysis) used.
- Description of all materials and equipment used, including the source and lot number of all starting materials and test compounds.
- Date each activity was performed.
- Location of records and materials: Clearly identified location(s) of data files and their content.
- Other supporting information needed for independent analysis of raw data obtained in experiment and interpretation of results.
- All raw, processed, and final/reported data generated in the experiment.
- A proper cross-reference should be added if any raw data is kept separate from the experimental record and cannot be attached to the experimental record, or any raw data is obtained by other researchers performing supporting experiments.
- Expectation: A qualified reviewer should be able to:
- link figures, graphs, conclusions, and other summary data to the raw data that was processed/analyzed.
- link the summary data to the corresponding experiment described in a lab notebook entry.
- link the lab notebook entry to the raw data (e.g., where generated by an automated instrument).
- All related experimental records and supporting research must be linked/cross-referenced in the main experiment (via the respective unique identifiers).
- The raw data obtained in an experiment may be stored in a separate archival system but should be referenced in the experimental record (see 3.1.2 Procedures for how and when to record data).
- If a new analysis of data from previous experimental records needs to be performed to generate a new result or conclusion, a new experimental record should be created, which should clearly cross-reference the earlier experimental records (by their unique identifiers) and conclusions reached.
- The EQIPD template "Documentation Plan" located in folder 3.1 in the Dossier (and below in Section C) provides a central space to describe this Core Requirement. The document is also used in the Toolbox items 3.1.4 Data security and 2.3.1 Generation, recording, handling and archiving of raw data.
Extra care has to be taken:
- The author(s), all individuals who participated and/or contributed to the experiment, including, where applicable, recorder(s) must be clearly identified, so that the data can be traced, by name and date to each individual's contribution. The above ensures that the record is attributable.
- Clear guidelines and conventions on file-naming for all data files and experimental record should be established for consistency and traceability (see Traceability of data and any person having impact on data).
For technical non-public reports (e.g. R&D reports used in regulatory submissions), it is easy and fairly common to provide direct references to a lab notebook containing the relevant information.
For scientific publications, it is not common to include such references and the following options may be considered to establish traceability between published data and internal records:
- develop a “for internal use” system (e.g. a plain Excel file accessible to all members of the research unit) where reports about completed studies (and associated manuscripts and publications) are matched with the corresponding unique study IDs
- including unique study IDs or references to the laboratory notebooks in the publications themselves (e.g. in the supplementary materials)
- include unique study IDs in the preregistered protocols
PLEASE DO NOT FORGET
- To ensure traceability, each experimental record should have a unique identifier in accordance with the applicable procedure(s), e.g., SOPs.
- Responsibility for creating experimental records and documentation of the resulting data rests with the researcher who generates the data. If multiple researchers collaborate in data generation, then it should be identified as such.