Would you like a pdf of the MHRA’s Good Clinical Practice Guide?

Dr M | The SOP Doc:

This is Emma’s quick overview of the MHRA Good Clinical Practice Guide, which I came across today.

Written mainly by authors within the GCP inspectorate, the GCP Guide offers practical advice and recommendations on how to meet the legislative requirements of Statutory Instrument 2004/1031, the legislation that transposed the Clinical Trials Directive (2001/20/EC) into UK law.

It’s aimed primarily at UK researchers. But, because the UK legislation interprets this key piece of European Legislation, the MHRA considers the bulk of the GCP Guide relevant for other European Member States. They also proffer it as a useful tool in non-European countries, since, according to the MHRA website, “some of the basic principles and good practice examples discussed in the guide will also be applicable beyond Europe”.*

Wonder why they didn’t provide it in pdf format? Like Emma says – much more useful. Don’t you agree?

 

*http://www.mhra.gov.uk/Howweregulate/Medicines/

Inspectionandstandards/GoodClinicalPractice/GoodClinicalPracticeGuide/index.htm

Originally posted on Signs & Symptoms of Translation:

Last week, the Medicines and Healthcare products Regulatory Agency (MHRA) published a brand new Good Clinical Practice Guide on clinical trials conducted in the UK. I received my copy by post a few days ago and thought I’d review it here.

The Guide is based on Clinical Trials Directive 2001/20/EC, which governs the conduct of clinical trials across the EU, so it will be a useful additional resource for medical translators who work into or out of English. Unfortunately, it’s only available as a printed book. This is disappointing because PDF format or online access would have made it much more practical for searching.

Contents

The 500-plus page GCP Guide has 14 chapters that cover a wide range of topics such as Sponsors, Research Ethics Committees, Pharmacovigilance, Statistics, Monitoring and Quality Systems. There is a useful list of Abbreviations and a Glossary of common terms. For more details on the contents…

View original 364 more words

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What’s the difference between protocol deviations and violations according to GCP?

Is the difference between a protocol deviation and a protocol violation a matter of interpretation, or does GCP provide an answer?

Real world or ideal world?

In an ideal world, protocol violations would not occur, but since we must deal with the world we live in, this difference is considered most often in terms of the degree of effect on data integrity or credibility. It may be argued that despite departing from the protocol, a protocol deviation is an “allowable” instance of protocol non-compliance, with minor consequences, in terms of its effect on the subject’s rights, safety or welfare, or the integrity of study data. For example, there may be occasions when study visits or tests will fall outside the acceptable visit “window”, due to public holidays for example, or for other unforeseen reasons, such as study subjects having transport issues causing them to miss or postpone their visit date.

In practical terms, such minor deviations from the protocol tend to be agreed in advance with the study sponsor, having been assessed as making little difference to study subjects’ safety, or to data analysis of primary or secondary objectives.

By contrast, a protocol violation is an incident with potentially serious consequences that could critically affect data analysis (casting doubt on its reliability/integrity) – aside from having put patients’ safety at risk. Generally, such incidents (most often picked up during monitoring) tend to involve unintentional non-compliance with study protocol inclusion/exclusion criteria.

Then again, no one can foresee the effects of protocol deviations on data analysis, which is why every effort should be made to limit their effects. That is, a large number of ‘minor’ deviations arising on one study site, or from across all sites, could impact analysis, affecting both ethical and statistical validity, thus compromising patient safety and data integrity. From a quality assurance perspective, a large number of minor deviations across sites point to systematic non-compliance.

The question then becomes why?

For example, is it due to a global training issue, since from a quality control perspective, monitoring should pick up on ‘incidents’ in order to suggest corrective actions. Or, is systematic non-compliance due to an aspect of trial design, in which case a timely protocol amendment would be appropriate corrective action?

To decide on appropriate action, perhaps we need to go back to basics – to review what protocol violations/deviations mean in GCP terms.

Think patient safety first

According to GCP, the distinction between a protocol deviation/violation is about responsibilities – for the investigator, these are defined in Section 4.5: Compliance with Protocol; and for the sponsor, they’re defined in Section 5.20: Noncompliance from ICH GCP.

ICH GCP section 4.5.4 states:-

The investigator may implement a deviation from, or a change of,  the  protocol to eliminate  an  immediate  hazard(s) to trial subjects without prior IRB/IEC approval/favourable opinion. As soon as possible, the implemented deviation or change, the  reasons for it, and, if appropriate, the proposed protocol amendment(s) should be submitted:

a)    to the IRB/IEC for review and approval/favourable opinion,
b)   to the sponsor for agreement and, if required,  
c)    to the regulatory authority(ies).

ICH GCP section 5.20 states:-

5.20.1 Non-compliance with the protocol, SOPs, GCP, and/or applicable regulatory requirement(s) by an investigator/institution, or by member(s) of the sponsor’s staff should lead to prompt action by the sponsor to secure compliance.

5.20.2 If the monitoring and/or auditing identifies serious and/or persistent noncompliance on the part of an investigator/institution, the sponsor should terminate the investigator’s/institution’s participation in the trial. When an investigator’s/institution’s participation is terminated because of non-compliance, the sponsor should notify promptly the regulatory authority(ies).

In effect, GCP recognises that deviations will occur, and that investigators/sponsors will work together in these instances to protect patients and to ensure data integrity. However, ultimately, when investigators’ fail in their responsibilities, serious and/or persistent protocol non-compliance (i.e. violation) warrants site suspension/closure by the study sponsor, if they are to fulfil their obligations to protect patients.

Therefore, if the distinction between a protocol deviation and a protocol violation is considered in terms of investigators’/sponsors’ responsibilities and corrective actions, then it becomes clear: with a deviation, both parties do what they can to protect trial subjects (as per ICH GCP section 4.5), since despite everyone’s best efforts, they will arise.

But, if investigators fail in their responsibilities, as indicated by persistent failure to either adhere to the protocol, or to implement the sponsor’s requirements, how should a sponsor handle this, in terms of corrective actions?

In terms of GCP requirements, specified in section 5.20.2, the sponsor must view protocol non-compliance as a ‘violation’ of agreed responsibilities. As such, the necessary corrective actions, then need to be detailed in Standard Operating Procedures (SOPs), or Work Instructions (WIs). For example, when serious and/or persistent non-compliance is identified, GCP would require that: the investigator’s participation must be terminated and regulatory authorities notified, accordingly.

Surely, incorporating such steps into an SOP or WI demonstrates the translation of these GCP standards into action?

(This post is based on my comments given in a discussion on this topic on LinkedIn, Clinical Research Professionals group, Jan/Feb 2011.)

Recommended Links

E6 ICH GCP

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Regulatory requirements: differences or similarities between FDA and EMA?

Following on from Carl Anderson’s guest post a week or two ago, I thought I’d bring you an update, about the Clinical Trials Register going live on the 22nd March 2011.

Clinicaltrials.gov

Carl’s post mentioned the website ClinicalTrials.gov. This is a public registry of clinical trials, established as a joint venture between the U.S. National Institutes of Health (NIH), and the FDA. Since 2007, the site has enabled trial sponsors/investigators to fulfil the US requirement to register all ‘applicable’ clinical trials, conducted under Food and Drug Administration (FDA) regulations. By September 2008, the site also enabled summary results of these trials to be reported.

In Europe, all clinical trials requiring authorisation have to go into a database, known as EudraCT. The requirement for this database was established under Directive 2001/20/EC article 11, on 1 May 2004. The database, hosted and run by the European Medicines Agency (EMA), contains information about all ongoing or completed clinical trials, in order for Member States (MS) to maintain oversight of clinical trials and investigational medicinal product (IMP) development through data sharing and coordination.

Home of EudraCT/EU Clinical Trials Register

Initially, only competent authorities (MS authorities responsible for authorising clinical trials in their territory) had access to the database, as well as responsibility for entering data. Subsequent changes to European Union (EU) pharmaceutical legislation (article 57 of the Regulation (EC) No 726/2004 and article 41 of the paediatric Regulation (EC) No 1901/2006) now mean that some of the information held in the EudraCT database is publicly available via the EU Clinical Trials Register website.

So, users can now find both historical and current information on this new website about interventional clinical trials on medicines, such as:

  • study design
  • study sponsor
  • the IMP
  • therapeutic areas involved
  • location of investigator sites in EU Member States and the European Economic Area, and finally,
  • the status of the clinical trial.

The new website also includes information about clinical trials conducted outside the EU/EEA if they form part of a Paediatric Investigation Plan (PIP).

However, data in the new EU Clinical Trials Register website may appear incomplete or inconsistent. The most obvious example concerns the status of the trial, where some studies may show as ongoing, when the end-date has not been updated by the national medicine regulatory authority of the MS.

Also, unlike the US ClinicalTrials.gov website, information about the results of clinical trials isn’t provided on the EU Clinical Trials Register website. Even so, as the European Public Health Alliance stated in their announcement about the website going live “this public information is a breakthrough for freedom of information and for greater transparency of the clinical trial process“.

So, what do you think: are the US and EMA Clinical Trial registries more alike than different in purpose and content?

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SOPs: recipe for organisational effectiveness or effective-mess?

Are your SOPs overly complex?

Have you ever wondered whether there’s a straightforward relationship between the number of staff in an organisation, the complexity of its procedures and the probability of error?

Years ago, an imaginative paper in the Quality Assurance Journal* described this relationship, humorously, in terms of the law of confusion, based on the premise that: If we’re all confused about some, if not all, aspects of our work, then the more of us there are, the greater the overall level of organisational confusion will be.

The relationship between confusion (C), number of staff in an organisation (N) and the complexity of procedures (cp) was shown as: C= Ncp.

So, according to this premise, introducing overly complex rules (policies) and procedures risks an exponential rise in organisational confusion, mainly due to saturating the human brain’s capacity to retain and act on supplied information. (In simple terms, we’re talking about confusion caused by information overload.)

It gets worse, in compliance terms: direct proportionality between confusion and error rate (er) means that more confusion leads to more error, where C er.

Combining these equations reveals that “the probability of error is directly proportional to the number of people in an organisation and exponentially proportional to the complexity of procedures they must follow”.

So, when it comes to SOPs, how do we resolve organisational confusion?

Consider that the solution may not just be about training to reduce confusion as a root cause of error, but may involve reducing complexity in your SOPs, or SOP sets, and increasing clarity through simplifying, where possible to reduce errors.

What are your principles for QA?

Taking steps to ensure that your SOPs are a recipe for organisational effectiveness and not effective-mess might mean adopting some basic principles for quality assurance (helpful when reviewing your SOPs for GCP compliance).

Suggested principles are: simplicity; effectiveness (doing the right QA); and efficiency (doing QA the right way). Following them means “…focusing QA resources on the most critical areas in an effective manner, while reducing unnecessary complexity whenever possible”.

Anyone care to share their experiences or tips with improving SOPs?

*Jones, Anthony B. Principles in quality assurance Part 1. Sink or swim.  The Quality Assurance Journal, 6 (4): 219–225, December 2002.

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Regulatory requirements: differences between FDA and EMA

As promised, and announced at the end of last week, this week’s post is from Carl Anderson, a U.S. based regulatory affairs and quality assurance consultant. Carl specialises in the field of FDA health product approvals including drugs, biologics, and medical devices. From 1987 to 2005 he worked for the United States Food and Drug Administration, primarily conducting inspections in the Bioresearch Monitoring program, which includes clinical trials.

Here is his guest commentary concerning different approaches in the USA and Europe to the enforcement of GCP in the conduct of clinical trials.

*****

FDA and EMA: Differences in Approach

by Carl Anderson

The United States Food & Drug Administration (FDA) has just released a new inspection guidance (Compliance Program) for GCP inspections of Sponsors and CROs (CP 7348.810: Sponsors, Contract Research Organizations, and Monitors). The guidance is for FDA staff conducting GCP inspections and is the equivalent of the EMA Annex IV: Sponsor site and/or Contract Research Organizations (CRO) inspections procedure. The biggest difference is the FDA Compliance Program makes no mention of Essential Documents found in the trial master file, the TMF. EMA has numerous documents requiring review of Essential Documents including the following in Annex IV:

Determine if all essential documents listed in the section 8 CPMP/ICH/135/95 Note for guidance on GCP, are available during the inspection.” The CPMP/ICH/135/95 Note for guidance on GCP is referred to in the United States as “ICH E6: Good Clinical Practice: Consolidated Guidance (ICH E6). The FDA Compliance Program does not mention ICH E6 even though it is an official FDA Guidance Document that was published in the U.S. Federal Register in 1996.

Another significant difference is that FDA does not have requirements for written procedures in clinical trials. The only exceptions are for monitoring plans in medical device trials and extensive SOPs required for Institutional Review Boards (IRBs/IECs). Note: There are no SOP requirements for clinical sites (none). SOPs or written procedures are sometimes referenced in the Sponsor/CRO Compliance Program but never as a requirement. Here is one passage:

Obtain a copy of the sponsor’s/CRO’s/monitor’s written procedures (SOPs and guidelines) for monitoring and determine if the procedures were followed for the selected study. In the absence of written procedures, conduct interviews of the monitors as feasible and/or otherwise determine how monitoring was conducted.”

There are several other requirements that are unique to FDA inspections. One is a new requirement that clinical trials be registered on the website ClinicalTrials.gov. It is a requirement of the United States Congress. The Compliance Program states: ClinicalTrials.gov is a website maintained by the National Library of Medicine (NLM). Its establishment was mandated by the 1997 FDA Modernization Act (FDAMA) to provide a public resource for information on studies of drugs, including biological drug products.” This is a requirement of all clinical trials conducted under FDA regulations that include an Investigational New Drug application (IND) for drugs and biologics and an Investigational Device Exemption (IDE) for medical devices. There are also regulatory requirements for financial disclosure and emergency research that are specific to FDA.

One way I have heard the difference between EMA and MHRA inspections from FDA inspections is that the European inspections are process driven, while FDA inspections are more detail oriented and focus on specific regulatory requirements. The roots of the differences in clinical trial regulations are that they were written at different times in the evolution of clinical research. FDA’s regulations are a result of the Thalidomide tragedy of the early 1960s that culminated in passage of the Kefauver-Harris amendments of 1962. Senator Estes Kefauver of Tennessee was a colorful character in United States politics, who was known for wearing a coonskin hat and dueling with President John F. Kennedy.

The European regulations are the result of the Clinical Trials Directive of 2001, almost 40 years later when clinical research looked very different. The ICH GCP Guidelines are far more specific than anything from FDA. The differences have made harmonisation and FDA/EMA collaboration very difficult.

Web Links: ClinicalTrials.gov: http://clinicaltrials.gov/

FDA Compliance Programs for Sponsor/CRO, Clinical Investigators, IRBs (Bioresearch Monitoring Program) Read Section III, Inspectional:

http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm160670.htm

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Forthcoming Guest post from Carl Anderson – the GxP Guru

Next week, I’m thrilled to announce that I’ll be hosting a guest post from Carl Anderson, the GxP Guru.

Carl Anderson - the GxP Guru

Before I set up this blog, I regularly read Carl’s to get the head’s up on what’s happening GxP-wise. He’s definitely the go-to man when it comes to getting updates re FDA developments etc. Carl worked for the FDA for a good many years, so has an insider’s view.

Imagine my delight when he kindly suggested that we guest post for each other –  with me being a newbie and all (blogger, that is). So, if you want to know more about “Is there a legal requirement to have SOPs for GCP in Europe?”, then check out my post on his blog.

Meanwhile, you’ll find him on my blogroll on the right hand side (GxP Perspectives). I’d also recommend that you subscribe to his blog, if you want to stay in the loop re GxP.

Over to you, Carl…

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What SOPs do sponsors need to demonstrate GCP compliance?

The need for SOPs in ICH-GCP (5.1.1) is clear: “The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s)”. Mentions of SOPs are scattered throughout ICH-GCP section 5, in relation to sponsor responsibilities.

However, before the Directives for Clinical Trials (Directive 2001/20/EC) and GCP (Directive 2005/28/EC) were implemented, you’d have been hard pressed to find any stipulations, or guidelines, about which sponsor SOPs were needed to demonstrate that trials are conducted in compliance with GCP, or applicable regulations. To be fair, sponsors need to decide this for themselves, according to how their clinical research process is structured.

But, if you want to know more about inspectors’ expectations when reviewing sponsor/CRO SOPs, then let me explain where you can look.

Both these Directives set out the ethical requirements for the conduct of clinical trials, establishing ICH-GCP within a common legal framework through its adoption across the European Economic Area. (This includes the 27 Member States of the European Union, plus Iceland, Liechtenstein and Norway). As well as adopting the principles of Good Clinical Practice (GCP), both Directives refer to detailed guidelines intended to assist with interpreting the legislation, for its uniform application.

Such guidance, on the legal requirements applying to clinical trials, is available in Eudralex volume 10 (clinical trials guidelines) of the publications “The rules governing medicinal products in the European Union“. Eudralex is the collection of rules and regulations governing medicinal products in the European Union. As such, these reference documents contain all Community legislation about medicinal products for human and veterinary use.

However, just as the requirement for sponsor SOPs is not particularly emphasised in this legislation*, neither is it that obvious, at first glance, where to look in the guidance documents for more information.

So, let me point you in the right direction: go to Chapter IV (Inspections) of Eudralex Volume 10, and read Annex IV to Guidance for the conduct of GCP inspections – Sponsor and CRO. I think you’ll find it interesting. But remember, if you happen to have 101 SOPs for conducting clinical research, you won’t be criticised for that, provided they’re followed. And, provided they demonstrate that your clinical trials are conducted in accordance with GCP and applicable regulations.

So, it might be worth reviewing your SOP sets for gaps. The question is: do yours satisfy the requirements compiled in Annex IV?

*An implicit reference to the need for SOPs appears in Chapter 2, Good Clinical Practice for the design, conduct, recording and reporting of clinical trials of the GCP Directive in Section 1, Article 2 (4): “The necessary procedures to secure the quality of every aspect of the trials shall be complied with.

Useful Links

For a summary of EU pharmaceutical legislation consult SCADPlus

Eudralex Reference Documents: Volume 10 Clinical Trials Guidelines

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What’s the difference between ICH-GCP and WHO-GCP?

This week’s post might seem like a bit of a digression, given the topic is about (Good Clinical Practice) GCP. But, then again, there’s a reason for that. Let me explain.

Although my blog posts so far have been about the generalities of Standard Operating Procedures (SOPs), in future posts I’ll focus a bit more on their significance for GCP in clinical research. So, to begin, I thought I’d provide a bit of context. Besides, occasionally the question comes up about which GCP we should be following in Europe, implying that there’s another standard. So, is there a GCP standard other than ICH E6 GCP?

Yes, there is another GCP standard (aside from FDA GCP). Namely, the WHO’s Guidelines for GCP. And no, it’s not the pop group from the 1960s, but the World Health Organisation. The WHO started the process of developing guidelines in the late 1960’s. By the mid-1970s, one of their Scientific Groups formulated proposals and guidelines for research in the field of drug development, which eventually concluded with the WHO-GCP guidelines being published in 1995. These reports also provided the basis for the ICH-GCP, as an international guideline (published in 1996). So, the WHO-GCP guidelines and ICH-GCP were more or less written in parallel, by some of the same experts, and are basically similar. Differences in content and style reflect differences in their intended purpose.

On the one hand, ICH-GCP was intended as a harmonised guideline, in the three main ICH regions (the USA, Japan and Europe), to meet the “Technical Requirements for Registration of Pharmaceuticals for Human Use”. It was meant for adoption as a regulatory standard wherever trials were performed, irrespective of local regulatory requirements (unless these were more demanding than ICH-GCP). By contrast, WHO-GCP was intended as an informative tool for less experienced users, including regulatory agencies in countries where no other guidance existed.

The WHO also published a Handbook in 2002, which is a fairly comprehensive read. Wearing my hat as a trainer, I’d recommend it as a bit of “light” bedside reading for everyone involved in clinical research. It not only explains how to apply the principles of GCP, but provides Q&A, as well as references for ethics committees, investigators, sponsors and regulators. Covers all the bases, I’d say.

In the meantime, the principles of ICH-GCP were adopted into European legislation, in 2001, with the implementation of the Clinical Trials Directive (Directive 2001/20/EC). This Directive provided a common legal framework across Member States for monitoring and enforcing GCP standards applicable to clinical research. The GCP Directive (Directive 2005/28/EC) clarified the principles of GCP, with detailed guidelines setting out EU requirements for such aspects as: the manufacture or importation of investigational medicinal product (IMP); Trial Master File (TMF) and archiving; and inspectors and their inspection procedures – to name but a few. These guidelines are published in Eudralex Volume 10: Clinical Trial Guidelines.

So, to sum up, in case you don’t get round to that bedtime reading: the top-line difference between ICH-GCP and WHO-GCP is that ICH-GCP has 13 principles and WHO-GCP has 14.

But actually, it’s just that Principles 5 & 6 in WHO-GCP have been merged in ICH-GCP Principle 6. And, the order of some of the principles has been swapped around a bit. Apart from that, GCP is GCP regardless of whether it came from the International Conference on Harmonisation (ICH) or the WHO.  But, let’s not forget, although one made it into the “Statute” books, the other serves to educate in those parts of the world that haven’t quite got their act together yet, in a legal sense.

There’s a big gold star waiting for the reader who can tell me where it says this in the 2002 WHO Handbook: “This  handbook  can  be  adopted  or  referenced  by  WHO  Member States. Where national regulations or requirements do not exist or require supplementation, relevant regulatory authorities may designate or adopt these GCP principles and standards. Where national or adopted international standards are more demanding than WHO GCP, the former should take precedence.”

Links

ICH Topic E6 Note for guidance on good clinical practice

WHO Guidelines for GCP

WHO Handbook for GCP: Guidance for Implementation

European Medicines Agency

Eudralex Volume 10: Clinical Trial Guidelines

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7 reasons to make Standard Operating Procedures (SOPs) user-friendly

In clinical research, the need for Standard Operating Procedures (SOPs) is enshrined in the 13th principle of Good Clinical Practice (GCP): “Systems with procedures that assure the quality of every aspect of the trial should be implemented”.

In effect, procedures provide the foundation for control of clinical research conduct that a sponsor* needs, and that regulators expect.

UK Clinical Trial toolkit

That’s because Standard Operating Procedures (SOPS) are about decreasing variability in a process: as we decrease procedural variability, we increase process control. That is, we standardize small parts (the constituent procedures) to control the big picture (the overall process). So, SOPs that help management to control processes, and their outputs, via internal quality control (QC), serve 2 key purposes:-

  • functionally: in everyday operational terms they standardise procedural performance, and
  • strategically: they operate as a compliance tool

In functional terms this means that they enable us:-

  1. To capture (retain & transfer) organisational knowledge (which means that sponsors can decrease training time and/or increase training efficacy)
  2. To standardise performance and increase consistency. (This means that the likelihood of providing an end-product or service of consistently high quality, through consistent performance of specified tasks – defined in full compliance with regulatory requirements – is increased)
  3. To provide an historical snapshot of procedural performance.

Strategically they help us:-

  1. To fulfill compliance requirements (by demonstrating how we translate GCP requirements into actions)
  2. To communicate effectiveness measures (instilling stakeholders’ with confidence (investigators, patients, regulators) in our competence to provide products/service that consistently fulfil(s) requirements
  3. To decrease error rate/improve quality (which means that improvement & change is tracked and documented)
  4. To reduce unnecessary duplication of efforts & control information growth (which means that “need to know” information is simplified, since there should then be less of it to be aware of).

But, and its a big ‘but’, realising each of these 7 capabilities is challenging, not least because variation is a fact of life in clinical research conduct. Nevertheless, don’t you think that  having SOPs that are easy to read, understand, follow and perform, might make our quest to demonstrate the quality of our clinical research that little bit easier?

So, given the critical importance of their strategic and functional roles, these are my 7 reasons for having user-friendly SOPs. What are yours?

*Sponsor: defined both in the glossary of ICH E6 Guideline for GCP (1.53), and in Article 2 (Definitions) of Directive 2001/20/EC as “…an individual, company, institution or organisation which takes responsibility for the initiation, management and/or financing of a clinical trial“.

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What tools do you use to develop your Standard Operating Procedures?

A simple flowchart for troubleshooting a broke...

Image via Wikipedia

Over the years,  I’ve noticed that organisations have one thing in common with their approach to developing SOPs – each does it their own way.

For some, it’s a draining, time consuming activity. For others, it’s an opportunity for improvement. So, what accounts for this difference in attitude?

Using tools, like process mapping, to identify these opportunities locates potential pain points, which might need  prioritising (i.e. points in your process ripe for non-compliances, most likely through a lack of standardisation, duplication, or confusion).

Process mapping is a technique for visually representing a standardized process, breaking it down into constituent parts. The challenge then, is to identify all the steps and decisions in a process in diagrammatic form, capturing: -

  • the flow of information, documents, or materials
  • tasks within the process that transform inputs into outputs
  • where decisions need to be made along the chain
  • dependencies between the process steps

Outline process maps (or flowcharts) show all the actions undertaken, providing a dynamic view of how your organisation can deliver enhanced business value (e.g. improved quality outcomes in clinical research). Through using “what if scenarios” you can compare maps of the process “as is” with the process “to be”.

Swimlane flowcharts (otherwise known as deployment charts), represent actions according to where, or by whom, they’re performed.

Either method, of representing the component parts in a process, simplifies SOP content into a large-scale format, which makes it easier to convert into a written SOP.

As a team exercise, ideally, process mapping leads to communication between departments or functions with an open exchange of ideas, plugging gaps and eliminating overlaps. At the very least, as a basis for SOP development, it provides a common framework, introducing a systematic way of working, which is after all, a necessary part of standardisation. Isn’t it?

What tools does your organisation use to develop its SOPs?

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