Within the ERSPC-study, several committees have been installed for the surveillance of quality
and progess of the trial.
The following committees will be active in the surveillance of the project's quality and progress:

• Scientific Committee
• Data Monitoring Committee
• Causes of Death Committee
• Quality Control Committee
• International Epidemiology Committee
• PSA Committee
• Pathology Committee

The Scientific Committee (SC) consists two persons per participating center and is chaired by Prof. dr. Fritz H. Schröder, Urologist in Rotterdam (NL). Twice a year there will be a meeting with all the members of the Scientific Committee. At these meetings each participating center will give an update of their data.

The Data Monitoring Committee (DMC) has regular 2-yearly meetings and is chaired by Dr. Phillip Smith, Urologist in Leeds (GB).

General tasks of the committee:
The DMC will monitor the work and protocols of all participating study centers as well as the work of the other committees active in the study.
Information to the DMC will be provided in two ways, as 'raw data' annually and as 'filtered data' (information that has passed certain committees) for review.
The DMC has the power to review interim data and to determine whether the study (centre) needs change, discontinuation or to proceed, and to monitor all ethical aspects of the study. It has established flagging rules to do both. The secretary will coordinate information exchange between the study centers and the DMC.
Furthermore the DMC has composed the following tables which are to be completed annually by each study centre.
Table 1: Recruitment
Table 1B: Age distribution of men
Table 2: Uptake of screening
Table 3A: Assessment, biopsy, and cancer detection rates (1st screen)
Table 3B: Assessment, biopsy, and cancer detection rates (routine screen)
Table 4A: Clinical stage distribution of prostate cancers
Table 4B: Pathology stage distribution of prostate cancers
Table 4C: Gleason score distribution of prostate cancers
Table 5: Treatment by stage
Table 6: All-cause mortality rates
Table 7: Prostate cancer incidence rates
Table 8: Prostate cancer mortality rates

The Causes of Death Committee (CoD) functions at each study center and focus on the following question:
'Would this man have died at this moment if prostate cancer had not been present?'
Therefore, all death among patients who are diagnosed with PC within the study population are considered deaths due to prostate cancer unless another cause of death can be proven. This includes patients who have died as a result of the screening procedure, biopsy procedure, and treatment.
Each case will be discussed by the members of the committee who are not involved in the study. The cases will be presented to the committee anonymously, and blinded towards screening or control group.
Evaluation of each case is done by means of completion of two standardised forms.

The Quality Control Committee (QCC) is chaired by Dr. Stefano Ciatto, head of the department of Diagnostic Medical Imaging in Florence (I). The QCC meets on a 6-months regular basis or exceptionally on chairman or member request.
The QCC has been appointed by the ERSPC to:
1. verify that active centers fulfil to the admission criteria of ERSPC, by means of a questionnaire/checklist (see addendum 25) and of site visits, if needed.
2. verify that active centers have available (and agree to provide) a minimal data set to the centralized DMC, by means of questionnaire/checklist (see addendum 26), and of site visits if needed.
3. verify the compliance to the ERSPC protocol and the internal consistency of data according to a periodic check, based on the data set provided every year by active centers. Performance indicators will be provided to the QCC by DMC.
4. report to the SC the results of checks 1 and 2, suggesting that single centers are eligible to participate to ERSPC. Report to the SC any result from check 3, which suggests major deviations from protocol or data inconsistency, apparently not compatible with ERSPC requirements.

The Epidemiology Committee (EC) is chaired by Dr. Freda Alexander, Epidemiologist in Edinburgh (GB). The tasks of the EC are:
1. To monitor the conduct of the study, adherence to trial design insofar as these are relevant to final co-ordinated analyses, which are;
(i) the analysis of prostate cancer mortality and the interpretation of these results
(ii) analyses of sensitivity, sojourn time and survival leading to recommendations regarding choice of modalities for screening, frequency of screening and interim end-points for use in the future.
2. To be responsible on behalf of the SC for the administration of the centralised data-base. This authority will be exercised primarily by the chairperson of the epidemiology committee. Each center will supply data at six-monthly intervals.
3. To report to the SC of ERSPC to advise it on all matters relevant to the centralised statistical analysis and the appropriate use, protection and ownership of data held on behalf of the SC at the data centre. This must satisfy the dataprotection regulations of each country. Reports to be provided six-monthly.
4. To produce and evaluate routine reports on the centralised data. These will be presented to the SC of ERSPC, local trialists and other relevant sub-committees. The chairperson, on behalf of the committee, shall be responsible for the validity of those reports.
5. To scrutinise all trial protocols with respect to epidemiology aspects. To consider all protocols for 'grafted' studies (i.e., epidemiological and other studies which are independent but use the facilities affunded by trial framework).
6. To liaise in all these activities with the quality control committee and the data monitoring committee.

The PSA-standardisation committee is coordinated by Dr. Bert Blijenberg, Clinical Chemist in Rotterdam (NL). The first aim of this committee is the assessment of laboratory performance among all partners in the study.
For 1997 a quality control programme for total prostate-specific antigen (PSA) is proposed. The organisation of this programme is in the hands of the Dutch Quality Assessment Foundation. Six times per year two human serum samples will be sent to all partners. The elaboration of the results will be done statistically as well as graphically by using Youden plots.
In the future other activities will be focused on the standardisation of PSA assays and on the assessment of free and total PSA.

Please visit also the WebMicroscope

	ERSPC 2004
	ERSPC 2006

The chairman of the Pathology Committee is Prof. Theo van der Kwast, Pathologist in Toronto (CAN). The Pathology Committee will guard the uniformity in tissue processing and nomenclature of diagnosis and staging terms in the histopathological reporting of sextant needle biopsies, enhance the quality of histopathological diagnosis, and reduce the inter-observer variation particularly in grading and staging of prostatic adenocarcinomas. The Pathology Committee will use the following methods:
1. The pathology departments of all participating centers will report on sextant needle biopsies by using exclusively the diagnostic terms as mentioned at the Consensus Workshop on Prostatic Screening held in Antwerp (see Denis L, Murphy GP, Schröder FH. Cancer 1995; 75: 1178-1207). Ambiguous terms like atypia, suspect or "consistent with" may not be used.
2. All centers use a standardised reporting form.
3. Each center appoints a reference pathologist who is responsible for the completion of the prostatic needle biopsy forms. In addition he/she can be consulted by his/her colleagues.
4. The reference pathologist reviews all needle biopsies of patients reported to have lesion of indeterminate malignancy, a precancerous lesion or an overt malignancy.
5. The reference pathologist of all centers meet once a year and participate in a slide panel discussion. For this, each reference pathologist submits slides with:
- PC adenocarcinoma Gleason score 2-4 (N=2)
- PC adenocarcinoma Gleason score 5-6 (N=2)
- PC adenocarcinoma Gleason score 7-8 (N=2)
- PC adenocarcinoma Gleason score > 8 if any (N=1)
- dubious malignancy (N=4, if possible)
- low grade Prostatic Intra-epithelial Neoplasia (PIN) (N=2, if possible)
- high grade PIN (N=2, if possible)
- non-adenocarcinomas (if possible)
During the annual conference each slide will be evaluated (blindly) by each pathologist independently and their diagnosis will be compared.

The Pathology Committee consists of all reference pathologists and two or three external expert pathologists. The Committee reports to the Quality Control Committee.