Aim

This guideline highlights what is expected from mentors/project leaders in relation to the quality assurance guidelines.

Description

Each guideline is highlighted with an A, B, C or D and contains a 1-2 sentence description of what is expected from the project leader. The A, B, C and D are the minimum requirements, if a guideline is highlighted as C (controlling), the project leader may (of course) also do (D) it themselves, and should do more than just monitoring (B). This happens in the context of the guideline. See the detail section.

PREPARATION
1.1A-01 Ready to go
Assessment by the EMGO Scientific Committee;                            
D > The project leader has to do this him/herself before a researcher can be appointed by the EMGO Institute.

Registering with the Data Protection Board (College Bescherming Persoonsgegevens);
B > The project leader monitors whether the researcher registers the details.

Assessment by the Medical Ethics Committee;
C > The project leader reviews the protocols to be submitted to the METC (protocols, in general, are produced by the investigator).

Informing research participants about the study (including information about the central insurance policy of the VU University Medical Center) and receiving written consent from the participants;
B > The project leader ensures that the investigator carries this out.

Signing the confidentiality regulations and agreement.
C > The project leader ensures that the confidential regulations are observed during the project.
D > The project leader should also sign the associated confidentiality agreement.

Trial registration at the Netherlands trial register
B > De project leader ensures the investigator registers the trial.

Population Screening Act (Wet op het BevolkingsOnderzoek)
D > The project leader initiates the application (procedure takes months)

1.1A-02 Relationship with external funder
D > The project leader has to do this and can’t leave it to the investigator

1.1A-03 Handling privacy sensitive data
B > The project leader ensures the Use of Data in Health Research Code (Code Goed Gedrag) is observed, and where applicable ensures the investigator observes the Code.
C > The project leader ensures that the confidential regulations are observed during the project.
D > The project leader should also sign the associated confidentiality agreement (see 1.1A-01 as well).

1.1A-04 Use of human tissue
B > In respect of the publication of findings regarding human tissue, the project leader ensures that a written response is obtained to whether the research participants wish to be informed about the findings, prior to measurement and at the point of reporting back.
C > The project leader monitors whether the human tissue is being dealt with as described in the research protocol approved by the METc, and whether, once the study has been completed and published, the material is returned to the tissue provider or destroyed.

1.1A-05 Folders and file names on the PC
B > The project leader ensures the folder structure is/remains logical as the project progresses and more folders are added. This can be achieved by occasionally mentioning it during work meetings.

1.1A-06 Logbooks
B > The project leader ensures that a logbook is maintained by occasionally addressing the topic logbooks during work meetings.

1.1A-07 Back-ups
B > The project leader ensures that the investigator regularly makes thorough back-ups.

1.1A-08 Mentoring doctoral students and junior researchers
A > The project leader advises the Ph D student to consult the guideline
D > The Project leader consults this guideline.

RESEARCH DESIGN

1.1B-01 Research protocols
C > The project leader reviews the protocols to be submitted to the METC (protocols, in general, are produced by the investigator).
C > The project leader ensures that any changes to the protocols (made by the investigator) are sent to the METc.

1.1B-02 Systematic review
A > The project leader should advise the investigator to consult sources (e.g. those described in the guideline) and experts (appointed by the project leader or indicated in the guidelines) before writing the protocol for a systematic review.
C > The project leader inspects the review protocol, that is, he/she reads and adds comments to the protocol.
B > The project leader ensures that an information specialist is consulted about developing a search strategy for the review.
B > The project leader ensures that the selection and methodological assessments of the abstracts and articles are carried out independently by 2 reviewers (the investigator and someone else).
B > The project leader ensures the investigator properly documents the following matters: 1) the search strategy; 2) the selection of abstracts and articles (in a flow diagram) and reasons for exclusion; 3) decisions when assessing methodological quality; 4) possible data analysis (combining, calculating effect sizes).
C > The project leader reviews the calculations (syntax) for the most important outcome measure in the review (see guideline 1.4-02: General data analysis).

1.1.B-03 Advice and support
B > The project leader ensures that the investigator looks for advice and support in an adequate manner in respect of data management and methodology/statistics.

1.1B-04 Source population and sampling
A > The project leader advises the investigator in respect of 1) delineation of the domain, 2) identification of the source population, and 3) drawing a sample from the resultant study population.

1.1B-05 Randomisation
B > The project leader ensures that the investigator carries out a proper randomisation.

1.1B-06 Blinding
B > The project leader ensures that investigator applies the selected blinding procedure.

1.1B-07 Sample size and power calculations
D > The project leader calculates the sample size and/or power for the study in question, potentially in consultation with a statistician.

1.1B-08 Questionnaires: selecting, translating and validating
C > The project leader reviews the decisions taken by the investigator about using certain questionnaires, as well as any decisions to develop or translate a questionnaire. In other words, 1) the project leader actively contributes ideas about the concepts to be measured and the suitability of the questionnaire(s) for the target group and study, and 2) the project leader has knowledge of the clinimetric properties of the questionnaires. In practice these choices are often jointly made by the investigator and project leader on the basis of information collected by the investigator.
B > The project leader ensures that any translations of questionnaires and any potential validation of a translated questionnaire are carried out according to the guidelines.
B > The project leader ensures that the primary outcome (measures) of the study satisfy the criteria determined in the guideline.
C > The project leader inspects the validation study protocol, that is, he/she reads and adds comments to the protocol.
C > The project leader reviews the calculations (syntax) for the most important results in the validation study (see guideline 1.4-02: General data analysis).

1.1B-09 Physical measurement instruments
B > The project leader ensures that the investigator determines the level of measurement accuracy, the desired range of measurements and the maximum, acceptable level of measurement error.
C > The project leader reviews whether the chosen measurement instruments fulfil the predetermined requirements. This can be undertaken on the basis of information regarding the instruments’ measurement properties provided by the investigator.
B > The project leader ensures that the investigator 1) regularly calibrates the instruments used and reviews how well the instruments are working, 2) determines the measurement error of the instruments, 3) creates and maintains a measurement protocol and a logbook.

1.1B-10 Qualitative research
B > The project leader ensures that the investigator monitors the data.
A > The project leader should advise the investigator to read through the BMJ guidelines.

PREPARATIONS FOR DATA COLLECTION

1.1C-01 Pilot measurements
B > The project leader ensures that the investigator carries out a pilot study.

1.1C-02 Information analysis
B > The project leader ensures that the investigator meets the data manager to discuss the best way of entering and storing the research data and who should be responsible for this.

1.1C-03 Codebook
B > The project leader ensures that a well-organised codebook is produced. You may also have to work with the final file as a supervisor, and therefore the file needs to be well-structured.

1.1C-04 Methods and computer programmes for data entry and designing input screens
A > The project leader should advise the investigator to choose highly efficient and reliable methods and computer programmes for data entry and designing data entry screens.

1.1C-05 Recruiting and training data collectors
B > The project leader ensures the investigator appoints data collectors on the basis of a previously drawn-up qualification list.
C > The project leader monitors whether the investigator trains the data collectors in line with a proven protocol.

1.1C-06 Recruiting and training data entry clerks
B > The project leader monitors whether the investigator trains the data entry clerks in line with a proven protocol.

1.1C-07 Dealing with study participants
B > The project leader ensures that the investigator and/or research assistants are aware of the issues around dealing carefully with research participants and are sensitive to research participants’ needs when dealing with them; this can be achieved by referring them to this guideline and regularly asking them about the data collection process.
D > If a research participant has made a complaint, the project leader should inform the responsible professor and work together with the investigator to find a solution.

1.1C-09 Recruiting study participants with recruiters
B > For research involving general practices, the project leader should ensure that the investigator contacts the academic unit of general practice (Huisartsgeneeskunde) in order to obtain an overview of GP’s who have already been approached for research.
B > The project leader ensures that the investigator keeps the recruiters informed about study progress.
B > The project leader ensures that the investigator investigates causes for any drop in recruitment.
B > In the event that a research protocol needs to be modified due to a drop in recruitment, the project leader needs to ensure that the investigator informs the METc of these changes.
D > The project leader should explore opportunities for accreditation for participating GP’s.

1.2 DATA COLLECTION

1.2-01 Supporting & monitoring data collectors
B > The project leader ensures that the data collectors are being supervised and monitored by the investigator.
B > The project leader ensures that the investigator carries out analyses on the first set of data to review the quality of the data.

1.2-02 Supporting & monitoring data entry clerks
B > The project leader ensures the data entry clerks are being supervised and monitored by the investigator.

1.2-03 Monitoring and managing dataflow
B > The project leader ensures that the investigator: creates an administrative database in consultation with the Data Management department; tests this database and instructs the users on how to use it.

1.2-04 Data provided by third parties
D > The project leader needs to produce written agreements with the data suppliers.
B > The project leader ensures that the investigator assesses whether the data supplied are usable, and have been validated and reviewed.
B > The project leader ensures that the investigator explores and documents how the laboratory guarantees that the data provided are the right data.
B > The project leader ensures that the investigator makes agreements with the laboratory about the delivery of the data, quality guarantees, monitoring, and archiving of measurement values and methods.

1.2-05 Data provided to third parties
D > The project leader needs to produce written agreements with the third party.
B > The project leader needs to ensure that confidential details have been removed from the data supplied.

1.3 DATA PROCESSING

1.3-01 File maintenance
B > The project leader ensures that the investigator employs a consistent system allowing subsequent corrections to be carried out.

1.3-02 Data definitions
B > The project leader ensures that all variables are defined fully and clearly by the investigator, i.e. the variables are provided with labels, value labels and missing values.

1.3-03 Data entry accuracy
D > The project leader determines together with the investigator how data entry accuracy will be determined.
B > The project leader will ensure that the data entry review will be carried out in a timely fashion by the investigator.
C > The project leader will review the outcomes of the review of input errors.

1.3-04 Data cleaning
B > The project leader will ensure data cleaning is undertaken by the investigator in a manner described in the guideline, including documenting comments in a logbook during the data cleaning process.
C > The project leader will review the data cleaning documentation for clarity and completion.

1.3-05 Data transformation
B > The project leader ensures that transformed variables are stored under different names.

1.4 DATA ANALYSIS

1.4-01 Analysis plan
C > The project leader ensures the data analysis is initiated using a dynamic working document, i.e. the so-called analysis plan.
The project leader will advise the investigator when to consult a statistician.

1.4-02 General data analysis
C > The project leader should review the most important study analysis to ensure the investigator is using the right (statistical) techniques and associated syntaxes (see also 1.1B-03 Advice and Support).

1.4-03 Initial data analysis
B > The project leader ensures the investigator undertakes an initial, exploratory data analysis to obtain a first impression of the data.

1.4-04 Post-hoc and sensitivity analyses
B > The project leader ensures the investigator correctly carries out post-hoc and sensitivity analyses if required.

1.4-05 Data analysis documentation
B > The project leader ensures that the investigator documents the data analyses in syntaxes to allow others to access and replicate the analysis at a later stage. The project leader should ensure this happens when the data are transferred (see guideline 1.5-01 Transfer).

1.4-06 Reporting results in tables and graphs
A > The project leader will advise the investigator on presenting results in graphs and tables.

1.4-07 Guidelines for reporting specific types of studies
C > The project leader if the proper guideline is followed

1.4-08 Prognostic models
A > The project leader will advise the investigator to use this guideline en if necessary consult an expert on modelling

TRANSFER AND ARCHIVING

1.5-1 Transfer
C > The project leader ensures the relevant documents have been handed over to the Data Management department (by the investigator).
C > The project leader reviews whether the syntaxes are clear enough to enable the analyses to be replicated.

1.5-2 Researchers leaving
D > The project leader makes the proper agreements with the leaving investigator in a timely fashion.

A = advising (indicating that it needs to be done)
B = monitoring (asking whether it has in fact been done)
C = controlling (determining for yourself that it has been done)
D = doing (doing it yourself, perhaps with help from others)

V1.1: 1 Jan 2010: English translation and update.
V1.0: 4 Dec 2008.

Does the project leader consults this guideline?